FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
PMA Final Decisions Rendered for 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.
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 DetectorTM | Logicon RDA
Los Angles, CA 90009 |
The Logicon Caries DetectorTM 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® NeptuneTM X-act® and the NeptuneTM 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® NeptuneTM X-act® and the NeptuneTM 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 RANGERTM Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Scimed Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for a new indication for the SCIMED® QUANTUM RANGERTM PTCA Catheter. The new indication is for post-delivery expansion of balloon expandable stents. |
P860019/S143
9/16/98 |
SCIMED® VIVATM and LONG VIVATM 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® VIVATM PTCA Catheters and SCIMED® LONG VIVATM 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 ANALYZERTM 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 PlusTM 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 PlusTM 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 |
LaCrosseTM, ChampionTM WrapTM, ChampionTM NC, and WrapTM NC PTCA Catheter Product Lines | United States Surgical Corporation
Norwalk, CT 06856 |
Approval for modifications to the Y-adapter, packaging and labeling of the LaCrosseTM PTCA Catheter, WrapTM PTCA Cathter, ChampionTM NC PTCA Catheter and WrapTM 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-SealTM 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-SealTM 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 BionicsTM 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 |
BioLonTM 1% Sodium Hyaluronate | Bio-Technology General Corp.
Iselin, NJ 08830 |
Approval for Akorn, Inc. to distribute BioLonTM 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 BionicsTM 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 |
LithoTronTM Ultra Lithotripsy System | HealthTronics, Inc.
Marietta, GA 30067 |
Approval for the following modifications to the LithoTronTM 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® RADIUSTM Coronary Stent with Delivery System | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for revisions to the Instructions for Use. |
*Evaluated as a "Real-Time Review" PMA Supplement.
APPLICATION NUMBER& 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
GFXTM 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
GFXTM 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. |
**A 135 Day Supplement Was Not Required
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 All PMA Submissions Received
Originals: 2
Supplements: 54
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
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH