Premarket Approval Decisions September 1998

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available. Information about the PDF Reader is available.

PMA Original Approvals

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
P970034 9/25/98	Ultraviolet-Absorbing Polymethylmethacrylate (PMMA) Posterior Chamber Intraocular Lenses (IOLs), Models RS-50B, RS-55B, RS-60B, and RS-65	Ophthalmic Innovations International, Inc. Claremont, CA 91711	Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation. The intraocular lens is intended to permanently replace the natural cataractous crystalline lens and to restore useful vision. It is intended for capsular bag placement only. The devices are available in a range of powers from 4 diopters (D) to 34D in 0.5D increments.
P980009 9/29/98	Magic WALLSTENT® Endoprosthesis	Schneider (USA) Inc. Minneapolis, MN 55442	Approval for the Magic WALLSTENT® Endoprosthesis. This device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length <35mm) with a reference vessel diameter of 3.0 to 5.5mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 3.0 to 5.5mm.
P980012 9/29/98	Novacor® LVAS	Baxter Healthcare Corporation Oakland, CA 94621	Approval for the Novacor® LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The LVAS is indicated for use both inside and outside the hospital.
P980017 9/25/98	Possis Perma-Seal® Dialysis Access Graft, Model 2C20	Possis Medical, Inc. Minneapolis, MN 55433-8003	Approval for the Possis Perma-Seal® Dialysis Access Graft, Model 2C20-B. This device is indicated for use as a subcutaneous arteriovenous shunt graft to provide immediate and subsequent chronic blood access for high-efficiency hemodialysis in patients who meet one or more of the following conditions: 1) central venous cannulation is deemed hazardous or is technically unavailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.
P980018 9/25/98	DAKO HercepTest	DAKO Corporation Carpinteria, CA 93013	Approval for the DAKO Herceptest. This device is a semi-quantitative immunohistochemical assay to determine HER2 overexpression in breast cancer tissues routinely processed for histological evaluation. HercepTest is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Transtuzumab) treatment is being considered.
P980025 9/25/98	Logicon Caries Detector^TM	Logicon RDA Los Angles, CA 90009	The Logicon Caries Detector^TM is a software decision aid for the diagnosis of caries that have penetrated into the dentin, on unrestored proximal surfaces of secondary dentition, through the analysis of digital intra-oral radiographic imagery. It is intended as an adjunct designed to work in conjunction with existing Trextrophy RVG digital x-ray radiographic system with TWI Software Version 3.0 or higher.

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE
TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

P970034

9/25/98

Ultraviolet-Absorbing Polymethylmethacrylate (PMMA) Posterior Chamber Intraocular Lenses (IOLs), Models RS-50B, RS-55B, RS-60B, and RS-65

Ophthalmic Innovations International, Inc.

Claremont, CA

91711

Indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular cataract extraction and primary lens implantation. The intraocular lens is intended to permanently replace the natural cataractous crystalline lens and to restore useful vision. It is intended for capsular bag placement only. The devices are available in a range of powers from 4 diopters (D) to 34D in 0.5D increments.

P980009

9/29/98

Magic WALLSTENT® Endoprosthesis

Schneider (USA) Inc.

Minneapolis, MN

55442

Approval for the Magic WALLSTENT® Endoprosthesis. This device is indicated for improving coronary luminal diameter in the following: 1) patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length <35mm) with a reference vessel diameter of 3.0 to 5.5mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 3.0 to 5.5mm.

P980012

9/29/98

Novacor® LVAS

Baxter Healthcare Corporation

Oakland, CA

94621

Approval for the Novacor® LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The LVAS is indicated for use both inside and outside the hospital.

P980017

9/25/98

Possis Perma-Seal® Dialysis Access Graft, Model 2C20

Possis Medical, Inc.

Minneapolis, MN

55433-8003

Approval for the Possis Perma-Seal® Dialysis Access Graft, Model 2C20-B. This device is indicated for use as a subcutaneous arteriovenous shunt graft to provide immediate and subsequent chronic blood access for high-efficiency hemodialysis in patients who meet one or more of the following conditions: 1) central venous cannulation is deemed hazardous or is technically unavailable; 2) are being maintained on chronic anticoagulation or antithrombotic therapy; and/or 3) are morbidly obese.

P980018

9/25/98

DAKO HercepTest

DAKO Corporation

Carpinteria, CA

93013

Approval for the DAKO Herceptest. This device is a semi-quantitative immunohistochemical assay to determine HER2 overexpression in breast cancer tissues routinely processed for histological evaluation. HercepTest is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Transtuzumab) treatment is being considered.

P980025

9/25/98

Logicon Caries Detector^TM

Logicon RDA

Los Angles, CA

90009

The Logicon Caries Detector^TM is a software decision aid for the diagnosis of caries that have penetrated into the dentin, on unrestored proximal surfaces of secondary dentition, through the analysis of digital intra-oral radiographic imagery. It is intended as an adjunct designed to work in conjunction with existing Trextrophy RVG digital x-ray radiographic system with TWI Software Version 3.0 or higher.

PMA SUPPLEMENTAL APPROVALS
APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
N50510/S083 9/15/98	Vitek Systems "General Susceptibility Card"	BioMerieux Vitek, Inc. Hazelwood, MI 63042-2395	Approval for the removal of a limitation for the testing of Pseudomonas aeruginosa with the antibiotic cefepime.
P790017/S067 9/18/98	USCI® Neptune^TM X-act® and the Neptune^TM X-act® Duo Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel® Coating and Anti Back Bleed Device	C.R. Bard, Inc. Billerica, MA 01821	Approval to market new PTCA catheter models. The devices, as modified, will be marketed under the trade names USCI® Neptune^TM X-act® and the Neptune^TM X-act® Duo Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel® Coating and Anti Back Bleed Device and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P800049/S008 9/4/98	Iridocapsular Intraocular Lenses (IOLs)	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P810001/S013 9/4/98	Anterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P810018/S036 9/4/98	Ultraviolet-Absorbing Posterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P810032/S049 9/4/98	Ultraviolet-Absorbing Posterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P820035/S015 9/4/98	Anterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P830039/S008* 9/25/98	Omniscience® Cardiac Valve	Medical, Inc. Inver Grove Heights, MN 55077	Approval for modifications to various cleaning methods utilized during production of the Omniscience® valve to remove chlorofluorocarbon solvents.
P830040/S026 9/4/98	3M Vision Care Posterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P830045/S056 9/4/98	APSu Programmer Model 3250 with model 3263 Software and Model 3251 Base Station with Model 3265 Software	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342-3577	Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.
P840024/S077* 9/25/98	Audallion Beamformer Noise Reduction System	Cochlear Corporation Englewood, CO 80112	Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejection of the overall RF interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available processor settings on the Audallion, enabling the device to be more user friendly.
P840060/S026 9/4/98	Posterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P850064/S014 9/16/98	Life Pulse High Frequency Ventilator	Bunnell, Inc. Salt Lake City, UT 84115	Approval for the addition of a caution to the labeling.
P860003/S032* 9/1/98	THERAKOS UVAR® Photopheresis System	THERAKOS Exton, PA 19341	Approval for a labeling change to include a natural rubber latex caution statement in the labels for the Photopheresis Procedural Kit, the Photoactivation Line, and the Photopheresis Procedural Kit Carton.
P860019/S141 9/30/98	SCIMED® QUANTUM RANGER^TM Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	Scimed Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for a new indication for the SCIMED® QUANTUM RANGER^TM PTCA Catheter. The new indication is for post-delivery expansion of balloon expandable stents.
P860019/S143 9/16/98	SCIMED® VIVA^TM and LONG VIVA^TM Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters	SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for new PTCA catheter models. The devices, as modified, will be marketed under the trade names SCIMED® VIVA^TM PTCA Catheters and SCIMED® LONG VIVA^TM PTCA Catheters and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
P870015/S030 9/16/98	Medstone STS-T Transportable Lithotripter	Medstone International, Inc. Alisa Viejo, CA 92656-4114	Approval for a transportable configuration of the Medstone STS lithotripter. The device, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated for use in fragmentation of upper urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
P870018/S021 9/21/98	Lithostar® Shock Wave System C Lithostar® Modularis	Siemens Medical Systems, Inc. Iselin, NJ 08830	Approval for a compact transportable (within the hospital only) configuration of the Lithostar® Shock Wave System C. The device, as modified, will be marketed under the trade name Lithostar® Modularis and is indicated for use in the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
P880006/S027 9/4/98	APSu Programmer Model 3250 with model 3263 Software and Model 3251 Base Station with Model 3265 Software	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342-3577	Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.
P880010/S019 9/4/98	Posterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P880086/S042 9/2/98	Trilogy DC+Pulse Generators, Model 2318L	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342-3577	Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.
P880086/S045 9/4/98	APSu Programmer Model 3250 with model 3263 Software and Model 3251 Base Station with Model 3265 Software	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342-3577	Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.
P880086/S046 9/3/98	Phoenix III Models 2204L and 2205M/S Paragon III Models 2304, 2305, 2314 and 2315	St. Jude Medical, Cardiac Rhythm Management Division Sylmar, CA 91392-9221	Approval for modifications to the approved labeling including: the addition of a "Cellular Tested" logo and associated language in the Patient and Physican manuals specifying those cellular telephone protocols for which testing has been performed and shown no interaction.
P880087/S007 9/4/98	Posterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P890003/S054 9/24/98	Medtronic "The Analyzer" Lead Analysis Device Model 8090	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Medtronic "The Analyzer" Lead Analysis Device Model 8090 including the Model 5436 Analyzer Patient Cable, the Models 5103 and 5104 Analyzer Adaptors, and the Model 8190 Version 1.1 Software. "The Analyzer" is attached to the Medtronic Model 9790 Programmer (approved as P890003/S027) and the Model 8190 Software is installed onto the hard drive of this Programmer. The device will be marketed under the trade name "Medtronic THE ANALYZER^TM Lead Analysis Device Model 8090" and is indicated for use by a clinician to assess the pacing and sensing performance of the lead system during arrhythmia management device implantation or during invasive lead system troubleshooting.
P890014/S002 9/16/98	DiaSorin ETI-HA-IGMK PLUS	DiaSorin/Medical Systems Group American Standard Companies Columbia Park, MD 21046	Approval for a change in the Enzyme tracer and Tracer Diluent from a IgG (sheep) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a change in the Positive Control material to a human source sera; the elimination of the mercury preservative in the reagents; a change in the incubation times from an overnight procedure to a four and one-half hour incubation; the addition of an indicator dye; and the addition of a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-HA-IGMK PLUS and is intended for use in the qualitative determination of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the diagnosis and monitoring of acute or recent hepatitis A virus infection.
P890019/S005 9/22/98	DiaSorin ETI-AB-HAVK PLUS	DiaSorin/Medical Systems Group American Standard Companies Columbia Park, MD 21046	Approval for a change in the Enzyme tracer and Tracer Diluent from an IgG (Human) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a change in the Positive Control and Negative Control materials to human source sera; the elimination of the mercury preservative in the reagents; and the addition of a neutralizing solution, incubation buffer and a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-AB-HAVK PLUS and is intended for the qualitative determination of total antiboides to hepatitis A virus (anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the diagnosis of current or previous hepatitis A virus infection and as an aid in the diagnosis of current or previous hepatitis A virus infection and as an aid in the identification of HAV-susceptible individuals for vaccination.
P890027/S046* 9/25/98	Audallion Beamformer Noise Reduction System	Cochlear Corporation Englewood, CO 80112	Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejection of the overall RF interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available procesor settings on the Audallion, enabling the device to be more user friendly.
P890055/S006 9/15/98	M-3000 Implantable Drug Delivery Pump with Bolus Safety Valve	Arrow International Walpole, MA 02081	Approval for the addition of Lioresal Intrathecal (baclofen injection) to the list of drugs approved for use with the M-3000 Implantable Drug Delivery Pump With Bolus Safety Valve.
P900052/S006 9/15/98	Port-A-Cath® Epidural Implantable Access System	SIMS Deltec, Inc. St. Paul, MN 55112	Approval for a change in the postapproval protocol to allow the use of anesthetics or analgesics approved for epidural delivery when toxicity symptoms related to the use of preservative-free morphine develop or if there is inadequate pain relief.
P900056/S024* 9/2/98	Rotablator® RotaLink Plus^TM Rotational Angioplasty System	Boston Scientific Corporation Northwest Technology Center, Inc. Redmond, WA 98052-3376	Approval to provide the Rotablator® RotaLink system to the user in a pre- connected configuration. The device, as modified, will be marketed under the trade name Rotoblator® RotaLink Plus^TM Rotational Angioplasty system and is indicated as a means of providing percutaneous rotational coronary angioplasty, as a sole therapy or with adjunctive balloon angioplasty, in patients with coronary artery disease who are candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria: 1) single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guide wire; 2) multiple vessel coronary artery disease that in the physician's judgment does not pose undue risk to the patient; 3) certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA), and who have a restenosis of the native vessel; or 4) native vessel atherosclerotic coronary artery disease that is less than 25mm in length.
P900070/S022 9/3/98	Tempo Models 1102, 1902, 2102 and 2902	St. Jude Medical, Cardiac Rhythm Management Division Sylmar, CA 91392-9221	Approval for modifications to the approved labeling including: the addition of a "Cellular Tested" logo and associated language in the Patient and Physican manuals specifying those cellular telephone protocols for which testing has been performed and shown no interaction.
P910023/S035* 9/3/98	Cadence® Tiered Therapy Defibrillator System	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086-6527	Approval for a modification of the defibrillation ports of the Ventritex® Contour® II Model V-185D Implantable Cardioverter Defibrillator (ICD).
P920014/S007 9/29/98	HeartMate® VE LVAS	Thermo Cardiosystems, Inc. Woburn, MA 01888-2697	Approval for the HeartMate® VE LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The HeartMate® VE LVAS is indicated for use both inside and outside the hospital.
P930012/S011* 9/2/98	LaCrosse^TM, Champion^TM Wrap^TM, Champion^TM NC, and Wrap^TM NC PTCA Catheter Product Lines	United States Surgical Corporation Norwalk, CT 06856	Approval for modifications to the Y-adapter, packaging and labeling of the LaCrosse^TM PTCA Catheter, Wrap^TM PTCA Cathter, Champion^TM NC PTCA Catheter and Wrap^TM NC PTCA Catheter product lines.
P930014/S003 9/4/98	Acrysof Posterior Chamber IOLs	Alcon Laboratories Fort Worth, TX 76134	Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."
P930038/S017* 9/25/98	Angio-Seal^TM Hemostatic Puncture Closure Device	Kendall Bothell, WA 98021	Approval for modifications to packaging system components (i.e., insulated shipping container, ice pack, component tray and guidewire tray) of the Angio-Seal^TM device.
P930039/S005 9/1/98	Medtronic CapSureFix® Steroid Eluting, Screw-In, Transveous Pacing Leads, Models 4067, 4068, 4568, 5068, and 5568	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for modifications to the CapSureFix® pacing lead family.
P940007/S004 9/29/98	Silicone Posterior Chamber Intraocular Lenses	Pharmacia & Upjohn Company Pickerington, OH 43147	Approval for a manufacturing site located at Pharmacia & Upjohn Groningen BV, Van Swietenlaan 5, NL-9728, NX Groningen, The Netherlands.
P940022/S006* 9/4/98	CLARION® Multi-Strategy Cochlear Implant	Advanced Bionics^TM Corporation Sylmar, CA 91342	Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following question and answer has been affixed to page 29: "Are there any restrictions on physical activities with CLARION?" "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, such as using a protective helmet to reduce the risk of device failure."
P950037/S004* 9/24/98	Actros DR, D, SR, and S Pulse Generators; PMS 1000 and PMS 1000C Programmers; and SWM 1000, Version F03.B00.U Software Module	Biotronik, Inc. Lake Oswego, OR 97035-5369	Approval for a slightly downsized header for the Actros DR, D, SR, and S pulse generators as well as approval for the Actros DR-A which is compatible with 5-mm leads and the Actros SR-B which is compatible with 6-mm leads. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, S, DR-A, and SR-B models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U).
P950043/S005 9/14/98	Econolith Lithotripter	Medispec, Ltd. Montgomery Village, MD 20886	Approval for relocation of manufacturing facility from Medispec, Ltd., 28 Hacharoshet St., Or-Yehuda, Israel to Medispec, Ltd., 24 Hatasiya St., Yahud, Or-Yehuda, Israel.
P960009/S002 9/1/98	Medtronic Activa Tremor Control System	Medtronic Neurological Minneapolis, MN 55440-9087	Approval of a protocol to assess the neurotoxicity and carcinogenicity of the Medtronic Model 3387 DBS Lead. The work performed under this protocol is intended to fulfill one of the four conditions of approval of the PMA.
P960011/S001 9/9/98	BioLon^TM 1% Sodium Hyaluronate	Bio-Technology General Corp. Iselin, NJ 08830	Approval for Akorn, Inc. to distribute BioLon^TM in the United States.
P960042/S002 9/4/98	14 French and 16 French Laser Sheath Kits	Spectranetics Corporation Colorado Springs, CO 80907-5186	Approval for the 14 French (Fr.) and 16 Fr. Laser Sheath Kits and individually packaged accessory devices (14 Fr. and 16 Fr. Outer Sheaths and Fish Tape). The Laser Sheath Kits include: one Laser Sheath (14 Fr. or 16 Fr.), two Outer Sheaths (14 Fr. or 16 Fr.), and a Fish Tape. The laser Sheath Kits, as modified, will be marketed under the trade names 14 Fr. and 16 Fr. Laser Sheath Kits and are indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.
P960043/S005 9/2/98	Prostar® XL 10 French Percutaneous Vascular Surgical (PVS) System	Perclose, Inc. Menlo Park, CA 94025	Approval for a modified Percutaneous Vascular Surgical (PVS) System. The device, as modified, will be marketed under the trade name Prostar® XL 10 French Percutaneous Vascular Surgical (PVS) System and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths.
P960058/S005* 9/4/98	CLARION® Multi-Strategy Cochlear Implant	Advanced Bionics^TM Corporation Sylmar, CA 91342	Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following question and answer has been affixed to page 29: "Are there any restriction on physical activities with CLARION?" "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, such as using a protective helmet, to reduce the risk of device failure."
P970012/S004 9/22/98	Medtronic.Kappa 400 Series Implantable Pulse Generators with version .13 firmware	Medtronic, Inc. Minneapolis, MN 55432	Approval for Version .13 firmware which incorporates Automatic Polarity configuration (APC).
P970019/S004 9/11/98	LithoTron^TM Ultra Lithotripsy System	HealthTronics, Inc. Marietta, GA 30067	Approval for the following modifications to the LithoTron^TM Lithotripsy System: 1) replacement of the transportable C-arm fluoroscopy system with an upgraded, stationary x-ray imaging system, 2) replacement of the existing patient table with one that offers Trendelenburg positioning, and 3) the addition of motorized movement of the shock wave therapy head. The device is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size,
P970030/S001 9/30/98	Toronto SPV® Valve, Model SPA-101	St. Jude Medical, Inc. St. Paul, MN 55117	Approval for the proposed post-approval study protocols submitted in response to FDA's conditions of approval, items 1 and 2.
P970031/S004 9/18/98	Medtronic FREESTYLE® Aortic Bioprosthesis	Medtronic Heart Valves, Inc. Santa Ana, CA 92705	Approval for the protocols to be used for the short term and long term post approval studies.
P970031/S005 9/18/98	Medtronic FREESTYLE® Aortic Bioprosthesis	Medtronic Heart Valves, Inc. Santa Ana, CA 92705	Approval for the protocols to be used for the short term and long term post approval studies.
P970038/S001 9/24/98	Tandem®-R free PSA assay and Tandem®-MP free PSA assay	Beckman-Coulter, Inc. Brea, CA 92822	Approval for changes to the patient labeling.
P970051/S001 9/21/98	Nucleus 24 Cochlear Implant System	Cochlear Corporation Englewood, CO 80112	Approval to strengthen the C124M implant case by adding a ceramic disc between the implant case and the ceramic feed through.
P970061/S003 9/15/98	SCIMED RADIUS Stent with Delivery Sytstem	Scimed Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for a manufacturing site located at Scimed Life Systems, One Scimed Place, Maple Grove, Minnesota.
P970061/S004 9/25/98	SCIMED® RADIUS^TM Coronary Stent with Delivery System	SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for revisions to the Instructions for Use.

PMA SUPPLEMENTAL APPROVALS

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE
TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

N50510/S083

9/15/98

Vitek Systems "General Susceptibility Card"

BioMerieux Vitek, Inc.

Hazelwood, MI

63042-2395

Approval for the removal of a limitation for the testing of Pseudomonas aeruginosa with the antibiotic cefepime.

P790017/S067

9/18/98

USCI® Neptune^TM X-act® and the Neptune^TM X-act® Duo Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel® Coating and Anti Back Bleed Device

C.R. Bard, Inc.

Billerica, MA

01821

Approval to market new PTCA catheter models. The devices, as modified, will be marketed under the trade names USCI® Neptune^TM X-act® and the Neptune^TM X-act® Duo Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel® Coating and Anti Back Bleed Device and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

P800049/S008

9/4/98

Iridocapsular Intraocular Lenses (IOLs)

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P810001/S013

9/4/98

Anterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P810018/S036

9/4/98

Ultraviolet-Absorbing Posterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P810032/S049

9/4/98

Ultraviolet-Absorbing Posterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P820035/S015

9/4/98

Anterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P830039/S008*

9/25/98

Omniscience® Cardiac Valve

Medical, Inc.

Inver Grove Heights, MN

55077

Approval for modifications to various cleaning methods utilized during production of the Omniscience® valve to remove chlorofluorocarbon solvents.

P830040/S026

9/4/98

3M Vision Care Posterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P830045/S056

9/4/98

APSu Programmer Model 3250 with model 3263 Software and Model 3251 Base Station with Model 3265 Software

St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342-3577

Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.

P840024/S077*

9/25/98

Audallion Beamformer Noise Reduction System

Cochlear Corporation

Englewood, CO

80112

Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejection of the overall RF interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available processor settings on the Audallion, enabling the device to be more user friendly.

P840060/S026

9/4/98

Posterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P850064/S014

9/16/98

Life Pulse High Frequency Ventilator

Bunnell, Inc.

Salt Lake City, UT

84115

Approval for the addition of a caution to the labeling.

P860003/S032*

9/1/98

THERAKOS UVAR® Photopheresis System

THERAKOS

Exton, PA

19341

Approval for a labeling change to include a natural rubber latex caution statement in the labels for the Photopheresis Procedural Kit, the Photoactivation Line, and the Photopheresis Procedural Kit Carton.

P860019/S141

9/30/98

SCIMED® QUANTUM RANGER^TM Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Scimed Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for a new indication for the SCIMED® QUANTUM RANGER^TM PTCA Catheter. The new indication is for post-delivery expansion of balloon expandable stents.

P860019/S143

9/16/98

SCIMED® VIVA^TM and LONG VIVA^TM Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters

SCIMED Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for new PTCA catheter models. The devices, as modified, will be marketed under the trade names SCIMED® VIVA^TM PTCA Catheters and SCIMED® LONG VIVA^TM PTCA Catheters and are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

P870015/S030

9/16/98

Medstone STS-T Transportable Lithotripter

Medstone International, Inc.

Alisa Viejo, CA

92656-4114

Approval for a transportable configuration of the Medstone STS lithotripter. The device, as modified, will be marketed under the trade name Medstone STS-T Transportable Lithotripter and is indicated for use in fragmentation of upper urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

P870018/S021

9/21/98

Lithostar® Shock Wave System C Lithostar® Modularis

Siemens Medical Systems, Inc.

Iselin, NJ

08830

Approval for a compact transportable (within the hospital only) configuration of the Lithostar® Shock Wave System C. The device, as modified, will be marketed under the trade name Lithostar® Modularis and is indicated for use in the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

P880006/S027

9/4/98

APSu Programmer Model 3250 with model 3263 Software and Model 3251 Base Station with Model 3265 Software

St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342-3577

Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.

P880010/S019

9/4/98

Posterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P880086/S042

9/2/98

Trilogy DC+Pulse Generators, Model 2318L

St. Jude Medical

Cardiac Rhythm Management

Division

Sylmar, CA

91342-3577

Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.

P880086/S045

9/4/98

APSu Programmer Model 3250 with model 3263 Software and Model 3251 Base Station with Model 3265 Software

St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342-3577

Approval for a manufacturing site located at Pacesetter AB, St. Jude Medical Cardiac Rhythm Management Division, Veddestavagen 19, Jarfalla, Sweden.

P880086/S046

9/3/98

Phoenix III Models 2204L and 2205M/S Paragon III Models 2304, 2305, 2314 and 2315

St. Jude Medical, Cardiac Rhythm Management Division

Sylmar, CA

91392-9221

Approval for modifications to the approved labeling including: the addition of a "Cellular Tested" logo and associated language in the Patient and Physican manuals specifying those cellular telephone protocols for which testing has been performed and shown no interaction.

P880087/S007

9/4/98

Posterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P890003/S054

9/24/98

Medtronic "The Analyzer" Lead Analysis Device Model 8090

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic "The Analyzer" Lead Analysis Device Model 8090 including the Model 5436 Analyzer Patient Cable, the Models 5103 and 5104 Analyzer Adaptors, and the Model 8190 Version 1.1 Software. "The Analyzer" is attached to the Medtronic Model 9790 Programmer (approved as P890003/S027) and the Model 8190 Software is installed onto the hard drive of this Programmer. The device will be marketed under the trade name "Medtronic THE ANALYZER^TM Lead Analysis Device Model 8090" and is indicated for use by a clinician to assess the pacing and sensing performance of the lead system during arrhythmia management device implantation or during invasive lead system troubleshooting.

P890014/S002

9/16/98

DiaSorin ETI-HA-IGMK PLUS

DiaSorin/Medical Systems Group

American Standard Companies

Columbia Park, MD

21046

Approval for a change in the Enzyme tracer and Tracer Diluent from a IgG (sheep) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a change in the Positive Control material to a human source sera; the elimination of the mercury preservative in the reagents; a change in the incubation times from an overnight procedure to a four and one-half hour incubation; the addition of an indicator dye; and the addition of a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-HA-IGMK PLUS and is intended for use in the qualitative determination of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the diagnosis and monitoring of acute or recent hepatitis A virus infection.

P890019/S005

9/22/98

DiaSorin ETI-AB-HAVK PLUS

DiaSorin/Medical Systems Group American Standard Companies

Columbia Park, MD

21046

Approval for a change in the Enzyme tracer and Tracer Diluent from an IgG (Human) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a change in the Positive Control and Negative Control materials to human source sera; the elimination of the mercury preservative in the reagents; and the addition of a neutralizing solution, incubation buffer and a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-AB-HAVK PLUS and is intended for the qualitative determination of total antiboides to hepatitis A virus (anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the diagnosis of current or previous hepatitis A virus infection and as an aid in the diagnosis of current or previous hepatitis A virus infection and as an aid in the identification of HAV-susceptible individuals for vaccination.

P890027/S046*

9/25/98

Audallion Beamformer Noise Reduction System

Cochlear Corporation

Englewood, CO

80112

Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejection of the overall RF interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available procesor settings on the Audallion, enabling the device to be more user friendly.

P890055/S006

9/15/98

M-3000 Implantable Drug Delivery Pump with Bolus Safety Valve

Arrow International

Walpole, MA

02081

Approval for the addition of Lioresal Intrathecal (baclofen injection) to the list of drugs approved for use with the M-3000 Implantable Drug Delivery Pump With Bolus Safety Valve.

P900052/S006

9/15/98

Port-A-Cath® Epidural Implantable Access System

SIMS Deltec, Inc.

St. Paul, MN

55112

Approval for a change in the postapproval protocol to allow the use of anesthetics or analgesics approved for epidural delivery when toxicity symptoms related to the use of preservative-free morphine develop or if there is inadequate pain relief.

P900056/S024*

9/2/98

Rotablator® RotaLink Plus^TM Rotational Angioplasty System

Boston Scientific Corporation

Northwest Technology Center, Inc.

Redmond, WA

98052-3376

Approval to provide the Rotablator® RotaLink system to the user in a pre- connected configuration. The device, as modified, will be marketed under the trade name Rotoblator® RotaLink Plus^TM Rotational Angioplasty system and is indicated as a means of providing percutaneous rotational coronary angioplasty, as a sole therapy or with adjunctive balloon angioplasty, in patients with coronary artery disease who are candidates for coronary artery bypass graft surgery and who meet one of the following selection criteria: 1) single vessel atherosclerotic coronary artery disease with a stenosis that can be passed with a guide wire; 2) multiple vessel coronary artery disease that in the physician's judgment does not pose undue risk to the patient; 3) certain patients who have had prior percutaneous transluminal coronary angioplasty (PTCA), and who have a restenosis of the native vessel; or 4) native vessel atherosclerotic coronary artery disease that is less than 25mm in length.

P900070/S022

9/3/98

Tempo Models 1102, 1902, 2102 and 2902

St. Jude Medical, Cardiac Rhythm Management Division

Sylmar, CA

91392-9221

P910023/S035*

9/3/98

Cadence® Tiered Therapy Defibrillator System

St. Jude Medical

Cardiac Rhythm Management Division

Sunnyvale, CA

94086-6527

Approval for a modification of the defibrillation ports of the Ventritex® Contour® II Model V-185D Implantable Cardioverter Defibrillator (ICD).

P920014/S007

9/29/98

HeartMate® VE LVAS

Thermo Cardiosystems, Inc.

Woburn, MA

01888-2697

Approval for the HeartMate® VE LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The HeartMate® VE LVAS is indicated for use both inside and outside the hospital.

P930012/S011*

9/2/98

LaCrosse^TM, Champion^TM Wrap^TM, Champion^TM NC, and Wrap^TM NC PTCA Catheter Product Lines

United States Surgical Corporation

Norwalk, CT

06856

Approval for modifications to the Y-adapter, packaging and labeling of the LaCrosse^TM PTCA Catheter, Wrap^TM PTCA Cathter, Champion^TM NC PTCA Catheter and Wrap^TM NC PTCA Catheter product lines.

P930014/S003

9/4/98

Acrysof Posterior Chamber IOLs

Alcon Laboratories

Fort Worth, TX

76134

Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle."

P930038/S017*

9/25/98

Angio-Seal^TM Hemostatic Puncture Closure Device

Kendall

Bothell, WA

98021

Approval for modifications to packaging system components (i.e., insulated shipping container, ice pack, component tray and guidewire tray) of the Angio-Seal^TM device.

P930039/S005

9/1/98

Medtronic CapSureFix® Steroid Eluting, Screw-In, Transveous Pacing Leads, Models 4067, 4068, 4568, 5068, and 5568

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for modifications to the CapSureFix® pacing lead family.

P940007/S004

9/29/98

Silicone Posterior Chamber Intraocular Lenses

Pharmacia & Upjohn Company

Pickerington, OH

43147

Approval for a manufacturing site located at Pharmacia & Upjohn Groningen BV, Van Swietenlaan 5, NL-9728, NX Groningen, The Netherlands.

P940022/S006*

9/4/98

CLARION® Multi-Strategy Cochlear Implant

Advanced Bionics^TM Corporation

Sylmar, CA

91342

Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following question and answer has been affixed to page 29: "Are there any restrictions on physical activities with CLARION?" "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, such as using a protective helmet to reduce the risk of device failure."

P950037/S004*

9/24/98

Actros DR, D, SR, and S Pulse Generators; PMS 1000 and PMS 1000C Programmers; and SWM 1000, Version F03.B00.U Software Module

Biotronik, Inc.

Lake Oswego, OR

97035-5369

Approval for a slightly downsized header for the Actros DR, D, SR, and S pulse generators as well as approval for the Actros DR-A which is compatible with 5-mm leads and the Actros SR-B which is compatible with 6-mm leads. The device, as modified, will be marketed under the trade name Actros Pacing System which consists of the following: Actros DR, D, SR, S, DR-A, and SR-B models, PMS 1000 C programmers, SWM 1000 (Version F03.B00.U).

P950043/S005

9/14/98

Econolith Lithotripter

Medispec, Ltd.

Montgomery Village, MD

20886

Approval for relocation of manufacturing facility from Medispec, Ltd., 28 Hacharoshet St., Or-Yehuda, Israel to Medispec, Ltd., 24 Hatasiya St., Yahud, Or-Yehuda, Israel.

P960009/S002

9/1/98

Medtronic Activa Tremor Control System

Medtronic Neurological

Minneapolis, MN

55440-9087

Approval of a protocol to assess the neurotoxicity and carcinogenicity of the Medtronic Model 3387 DBS Lead. The work performed under this protocol is intended to fulfill one of the four conditions of approval of the PMA.

P960011/S001

9/9/98

BioLon^TM 1% Sodium Hyaluronate

Bio-Technology General Corp.

Iselin, NJ

08830

Approval for Akorn, Inc. to distribute BioLon^TM in the United States.

P960042/S002

9/4/98

14 French and 16 French Laser Sheath Kits

Spectranetics Corporation

Colorado Springs, CO

80907-5186

Approval for the 14 French (Fr.) and 16 Fr. Laser Sheath Kits and individually packaged accessory devices (14 Fr. and 16 Fr. Outer Sheaths and Fish Tape). The Laser Sheath Kits include: one Laser Sheath (14 Fr. or 16 Fr.), two Outer Sheaths (14 Fr. or 16 Fr.), and a Fish Tape. The laser Sheath Kits, as modified, will be marketed under the trade names 14 Fr. and 16 Fr. Laser Sheath Kits and are indicated for use as an adjunct to conventional lead extraction tools in patients suitable for transvenous removal of chronically implanted pacing or defibrillator leads constructed with silicone or polyurethane outer insulation.

P960043/S005

9/2/98

Prostar® XL 10 French Percutaneous Vascular Surgical (PVS) System

Perclose, Inc.

Menlo Park, CA

94025

Approval for a modified Percutaneous Vascular Surgical (PVS) System. The device, as modified, will be marketed under the trade name Prostar® XL 10 French Percutaneous Vascular Surgical (PVS) System and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8.5F to 10F sheaths.

P960058/S005*

9/4/98

CLARION® Multi-Strategy Cochlear Implant

Advanced Bionics^TM Corporation

Sylmar, CA

91342

Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following question and answer has been affixed to page 29: "Are there any restriction on physical activities with CLARION?" "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, such as using a protective helmet, to reduce the risk of device failure."

P970012/S004

9/22/98

Medtronic.Kappa 400 Series Implantable Pulse Generators with version .13 firmware

Medtronic, Inc.

Minneapolis, MN

55432

Approval for Version .13 firmware which incorporates Automatic Polarity configuration (APC).

P970019/S004

9/11/98

LithoTron^TM Ultra Lithotripsy System

HealthTronics, Inc.

Marietta, GA

30067

Approval for the following modifications to the LithoTron^TM Lithotripsy System: 1) replacement of the transportable C-arm fluoroscopy system with an upgraded, stationary x-ray imaging system, 2) replacement of the existing patient table with one that offers Trendelenburg positioning, and 3) the addition of motorized movement of the shock wave therapy head. The device is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size,

P970030/S001

9/30/98

Toronto SPV® Valve,

Model SPA-101

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for the proposed post-approval study protocols submitted in response to FDA's conditions of approval, items 1 and 2.

P970031/S004

9/18/98

Medtronic FREESTYLE® Aortic Bioprosthesis

Medtronic Heart Valves, Inc.

Santa Ana, CA

92705

Approval for the protocols to be used for the short term and long term post approval studies.

P970031/S005

9/18/98

Medtronic FREESTYLE® Aortic Bioprosthesis

Medtronic Heart Valves, Inc.

Santa Ana, CA

92705

Approval for the protocols to be used for the short term and long term post approval studies.

P970038/S001

9/24/98

Tandem®-R free PSA assay and Tandem®-MP free PSA assay

Beckman-Coulter, Inc.

Brea, CA

92822

Approval for changes to the patient labeling.

P970051/S001

9/21/98

Nucleus 24 Cochlear Implant System

Cochlear Corporation

Englewood, CO

80112

Approval to strengthen the C124M implant case by adding a ceramic disc between the implant case and the ceramic feed through.

P970061/S003

9/15/98

SCIMED RADIUS Stent with Delivery Sytstem

Scimed Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for a manufacturing site located at Scimed Life Systems, One Scimed Place, Maple Grove, Minnesota.

P970061/S004

9/25/98

SCIMED® RADIUS^TM Coronary Stent with Delivery System

SCIMED Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for revisions to the Instructions for Use.

APPLICATION NUMBER&AMP; LTR DATE	DEVICE NAME	COMPANY NAME	COMMENTS

P960057/S001 9/11/98**	ADCON®-L Adhesion Control in a Barrier Gel	Gliatech, Inc. Cleveland, OH 44122	The 30-day Notice requested that FDA review a change in the manufacturing process. A Vertrod Thermal Impulse Heat Sealer will be used in place of an Audion Future Jaw clamp pouch sealer to seal the Tyvek pouch containing the aluminum tube of ADCON® -L Adhesion Control Barrier Gel. This change does not affect the currently approved Tyvek seal integrity testing method or specification.
P890017/S005 9/25/98**	Cordis PALMAZ® Balloon-Expandable Stent	Cordis Warren, NJ 07059	The 30-day notice requested that FDA review a change involving the transfer of an intermediate manufacturing process. The electropolishing of the metal stent and post-polishing stent inspection operation will be transferred from Corids Corporation to one of the suppliers, Norman Noble, Inc. of Cleveland, Ohio.
P970003/S010 9/25/98**	NeuroCybernetic Prosthesis (NCP) System	Cyberonics, Inc. Houston, TX 77058	30-day notice requested the addition of a cleanroom equivalent to one already in use.
P970035/S005 9/30/98**	Micro Stent® II Over-the-Wire Coronary Stent System GFX^TM Over-the-Wire Coronary Stent System	Arterial Vascular Engineering, Inc. Santa Rosa, CA 95403	Requested a change to utilize a circular"ring" light source to apply the UV light during the UV adhesive curing process. The requested change will provide constant 360 degree application of UV light to the UV adhesive and will no longer require rotation of the catheter assembly. This process change will eliminate the need for nitrogen cooling gas and will reduce the process time for the distal luer bond from 60 seconds to 38 seconds.
P970035/S007 9/30/98**	Micro Stent® II Over-the-Wire Coronary Stent System GFX^TM Over-the-Wire Coronary Stent System	Arterial Vascular Engineering, Inc. Santa Rosa, CA 95403	Requested a change in the current balloon bond process from a manual to an automated process.

APPLICATION NUMBER&AMP;
LTR DATE

DEVICE
NAME

COMPANY NAME

COMMENTS

P960057/S001**

9/11/98

ADCON®-L Adhesion Control in a Barrier Gel

Gliatech, Inc.

Cleveland, OH

44122

The 30-day Notice requested that FDA review a change in the manufacturing process. A Vertrod Thermal Impulse Heat Sealer will be used in place of an Audion Future Jaw clamp pouch sealer to seal the Tyvek pouch containing the aluminum tube of ADCON® -L Adhesion Control Barrier Gel. This change does not affect the currently approved Tyvek seal integrity testing method or specification.

P890017/S005**

9/25/98

Cordis PALMAZ® Balloon-Expandable Stent

Cordis

Warren, NJ

07059

The 30-day notice requested that FDA review a change involving the transfer of an intermediate manufacturing process. The electropolishing of the metal stent and post-polishing stent inspection operation will be transferred from Corids Corporation to one of the suppliers, Norman Noble, Inc. of Cleveland, Ohio.

P970003/S010**

9/25/98

NeuroCybernetic Prosthesis (NCP) System

Cyberonics, Inc.

Houston, TX

77058

30-day notice requested the addition of a cleanroom equivalent to one already in use.

P970035/S005**

9/30/98

Micro Stent® II Over-the-Wire Coronary Stent System

GFX^TM Over-the-Wire Coronary Stent System

Arterial Vascular Engineering, Inc.

Santa Rosa, CA

95403

Requested a change to utilize a circular"ring" light source to apply the UV light during the UV adhesive curing process. The requested change will provide constant 360 degree application of UV light to the UV adhesive and will no longer require rotation of the catheter assembly. This process change will eliminate the need for nitrogen cooling gas and will reduce the process time for the distal luer bond from 60 seconds to 38 seconds.

P970035/S007**

9/30/98

Micro Stent® II Over-the-Wire Coronary Stent System

GFX^TM Over-the-Wire Coronary Stent System

Arterial Vascular Engineering, Inc.

Santa Rosa, CA

95403

Requested a change in the current balloon bond process from a manual to an automated process.

Summary of PMA Originals & Supplements Approved
Originals: 6
Supplements: 55

Summary of PMA Originals Under Review
Total Under Review: 66
Total Active: 25
Total On Hold: 41
Number Greater Than 180 Days: 0

Summary of PMA Supplements Under Review
Total Under Review: 196
Total Active: 139
Total On Hold: 57
Number Greater Than 180 Days: 0

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 55
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 238.9
Number Greater Than 180 Days: 0

Updated 8/10/1999

horizonal rule

Center for Devices and Radiological Health / CDRH

PMA Final Decisions Rendered for September 1998

PMA Original Approvals