Premarket Approval Decisions September 1999

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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PMA Final Decisions Rendered for September 1999

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for September 1999. This list is generated on a monthly basis.

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

P970056

9/28/99

KERACOR® 116 Ophthalmic Excimer Laser System (16 Units)

Bausch & Lomb Surgical

Claremont, CA

91711

Approval for 16 units of the KERACOR® 116 ophthalmic excimer laser system. This device is indicated for myopic photorefractive keratectomy (PRK) in patients who meet the following criteria: 1) In Photorefractive Keratectomy (PRK) treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism. 2) In patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination. 3) In patients who are 18 yrs of age or older.

P980043

9/28/99

Medtronic Hancock® II Bioprosthetic Heart Valve, Models T505 and T510

Medtronic Cardiac Surgery

Minneapolis, MN

55432-3576

Approval for the Medtronic Hancock® II Bioprosthetic Heart Valve, Models T505 (odd sizes 21 through 29 mm) and T510 (odd sizes 25 through 33 mm). This device is indicated for the replacement of pathologic or prosthetic aortic and mitral valves.

P980049

9/15/99

Defender™ II Model 9201 Implantable Cardioverter Defibrillator

ELA Medical, Inc.

Plymouth, MN

55441

This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 2) recurrent poorly tolerated, sustained ventricular tachycardia (VT).

P980053

9/13/99

Durasphere™ Injectable Bulking Agent

Advanced UroScience, Inc.

Saint Paul, MN

55110

This device is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).

P990001

9/27/99

Diva Platform Implantable Pulse Generators and ProVit III Application Software (Version 3.3.2)

Vitatron, Inc.

Minneapolis, MN

55459

Approval for the Diva Platform Implantable Pulse Generators and the ProVit III Application Software (version 3.3.2) including the Diamond II Model 820 Pulse Generator; the Ruby II Model 720 Pulse Generator; the Topaz II Model 520 Pulse Generator; the Jade II Model 220 Pulse Generator; the Vita DDDR Model 810 Pulse Generator; the Vita DDD Model 710 Pulse Generator; the Vita VVIR Model 310 Pulse Generator.

P990002

9/30/99

FemSoft® Insert

Rochester Medical Corporation

Stewartville, MN

55976

Indicated for the management of stress urinary incontinence in adult females.

P990004

9/30/99

SURGIFOAM Absorbable Gelatin Sponge, U.S.P.

Ethicon, Inc.

Somerville, NJ

08876-0151

Approval for the SURGIFOAM Absorbable Gelatin Sponge, U.S.P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.

P990008

9/27/99

Cook® MBC PTCA Balloon Dilatation Catheter

Cook, Inc.

Bloomington, IN

47402

Approval for the Cook® MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure). This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.

P990017

9/28/99

Guidant Corporation

Menlo Park, CA

94025

ANCURE™ Tube System, ANCURE™ Bifurcated System, ANCURE™ Iliac Balloon Catheter

Approval for the ANCURE™ Tube and Bifurcated Systems and the ANCURE™ Iliac Balloon Catheter (9 mm to 14 mm sizes). This device has the following indications for use: The ANCURE™ Tube System is indicated for the endovascular treatment of infrarenal abdominal aortic aneurysms (AAA) in patients having adequate iliac/femoral access, infrarenal non-aneurysmal | Neck length of at least 15 mm and a diameter of no greater than 26mm, distal segment neck length of 12mm and diameter of no greater than 26mm, and morphology suitable for endovascular repair. The ANCURE™ Bifurcated System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients having adequate iliac/femoral access, infrarenal non-aneurysmal neck length of at least 15mm and a diameter of no greater than 26mm, distal segment lengths of at least 20mm and diameters no greater than 13.4mm, and morphology suitable for endovascular repair. The ANCURE™ Iliac Balloon Catheter is indicated for use in securing the attachment systems in the iliac arteries and/or to expand vascular prosthesis limbs of the ANCURE™ ENDOGRAFT® Vascular Prosthesis.

P990020

9/28/99

Medtronic AVE

Santa Rosa, CA

95407

AneuRx™ Stent Graft System

This device is indicated for the endovascular treatment of infra renal abdominal aortic or aorto-iliac aneurysms having: 1) Adequate iliac/femoral access; 2) Infrarenal non-aneurysmal neck length of at least 1 cm at the proximal and distal ends of the aneurysm, and a vessel diameter 10-20% smaller than labeled device diameter; 3) Morphology suitable for endovascular repair; and 4) One of the following: A diameter > 5cm; A diameter of 4-5cm and has increased in size by 0.5cm in the last 6 months; or Twice the diameter of the normal infrarenal aorta.

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P970056 9/28/99	KERACOR® 116 Ophthalmic Excimer Laser System (16 Units)	Bausch & Lomb Surgical Claremont, CA 91711	Approval for 16 units of the KERACOR® 116 ophthalmic excimer laser system. This device is indicated for myopic photorefractive keratectomy (PRK) in patients who meet the following criteria: 1) In Photorefractive Keratectomy (PRK) treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism. 2) In patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination. 3) In patients who are 18 yrs of age or older.
P980043 9/28/99	Medtronic Hancock® II Bioprosthetic Heart Valve, Models T505 and T510	Medtronic Cardiac Surgery Minneapolis, MN 55432-3576	Approval for the Medtronic Hancock® II Bioprosthetic Heart Valve, Models T505 (odd sizes 21 through 29 mm) and T510 (odd sizes 25 through 33 mm). This device is indicated for the replacement of pathologic or prosthetic aortic and mitral valves.
P980049 9/15/99	Defender™ II Model 9201 Implantable Cardioverter Defibrillator	ELA Medical, Inc. Plymouth, MN 55441	This device is indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; 2) recurrent poorly tolerated, sustained ventricular tachycardia (VT).
P980053 9/13/99	Durasphere™ Injectable Bulking Agent	Advanced UroScience, Inc. Saint Paul, MN 55110	This device is indicated for use in the treatment of adult women with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
P990001 9/27/99	Diva Platform Implantable Pulse Generators and ProVit III Application Software (Version 3.3.2)	Vitatron, Inc. Minneapolis, MN 55459	Approval for the Diva Platform Implantable Pulse Generators and the ProVit III Application Software (version 3.3.2) including the Diamond II Model 820 Pulse Generator; the Ruby II Model 720 Pulse Generator; the Topaz II Model 520 Pulse Generator; the Jade II Model 220 Pulse Generator; the Vita DDDR Model 810 Pulse Generator; the Vita DDD Model 710 Pulse Generator; the Vita VVIR Model 310 Pulse Generator.
P990002 9/30/99	FemSoft® Insert	Rochester Medical Corporation Stewartville, MN 55976	Indicated for the management of stress urinary incontinence in adult females.
P990004 9/30/99	SURGIFOAM Absorbable Gelatin Sponge, U.S.P.	Ethicon, Inc. Somerville, NJ 08876-0151	Approval for the SURGIFOAM Absorbable Gelatin Sponge, U.S.P. This device is indicated for surgical procedures (except urologic, ophthalmic and neurologic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical.
P990008 9/27/99	Cook® MBC PTCA Balloon Dilatation Catheter	Cook, Inc. Bloomington, IN 47402	Approval for the Cook® MBC PTCA Balloon Dilatation Catheter (sizes noted in the enclosure). This device is indicated for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
P990017 9/28/99	Guidant Corporation Menlo Park, CA 94025	ANCURE™ Tube System, ANCURE™ Bifurcated System, ANCURE™ Iliac Balloon Catheter	Approval for the ANCURE™ Tube and Bifurcated Systems and the ANCURE™ Iliac Balloon Catheter (9 mm to 14 mm sizes). This device has the following indications for use: The ANCURE™ Tube System is indicated for the endovascular treatment of infrarenal abdominal aortic aneurysms (AAA) in patients having adequate iliac/femoral access, infrarenal non-aneurysmal \| Neck length of at least 15 mm and a diameter of no greater than 26mm, distal segment neck length of 12mm and diameter of no greater than 26mm, and morphology suitable for endovascular repair. The ANCURE™ Bifurcated System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients having adequate iliac/femoral access, infrarenal non-aneurysmal neck length of at least 15mm and a diameter of no greater than 26mm, distal segment lengths of at least 20mm and diameters no greater than 13.4mm, and morphology suitable for endovascular repair. The ANCURE™ Iliac Balloon Catheter is indicated for use in securing the attachment systems in the iliac arteries and/or to expand vascular prosthesis limbs of the ANCURE™ ENDOGRAFT® Vascular Prosthesis.
P990020 9/28/99	Medtronic AVE Santa Rosa, CA 95407	AneuRx™ Stent Graft System	This device is indicated for the endovascular treatment of infra renal abdominal aortic or aorto-iliac aneurysms having: 1) Adequate iliac/femoral access; 2) Infrarenal non-aneurysmal neck length of at least 1 cm at the proximal and distal ends of the aneurysm, and a vessel diameter 10-20% smaller than labeled device diameter; 3) Morphology suitable for endovascular repair; and 4) One of the following: A diameter > 5cm; A diameter of 4-5cm and has increased in size by 0.5cm in the last 6 months; or Twice the diameter of the normal infrarenal aorta.

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
PMA SUPPLEMENTAL APPROVALS
N50510/S090 9/17/99	Vitek® 2 Gram Negative Susceptibility Test- Tobramycin	BioMerieux, Inc. Hazelwood, MI 63042-2320	Approval for the addition of the antibiotic tobramycin to the Vitek® 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 and is indicated for use in the Vitek® 2 gram negative susceptibility panel for the susceptibility testing of gram negative isolates to tobramycin in the range of £ 1 to ³ 16 m g/ml.
N50510/S091 9/23/99	Vitek® 2 Gram Negative Susceptibility Test for Ciprofloxacin	BioMerieux, Inc. Hazelwood, MI 63042-2320	Approval for the addition of the antibiotic ciprofloxacin at concentrations of 0.5, 2 and 4 m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 and is indicated for use in Vitek® 2 Gram Negative Susceptibility Test Cards for the susceptibility testing of gram negative isolates to ciprofloxacin in the range of £ 0.25 to ³ 4 m g/ml.
P790007/S016 9/29/99	Hancock Modified Orifice and Modified Orifice Conduit Aortic Bioprosthesis, Models 250 and 150, and Hancock Modified Orifice II Aortic Bioprostheses, Models 250B, 250C, 250D, and 250E	Medtronic Heart Valves Santa Ana, CA 92705	Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
P790018/S035 9/29/99	Medtronic Hall Prosthetic Heart Valve, Models A7700 and M7700, Aortic Valved Conduit Prosthesis, Model C7700, Rotatable Aortic Valved Collagen Impregnated Conduit, Model R7700, Aortic Valved Collagen Impregnated Conduit, Model Z7700	Medtronic Heart Valve Santa Ana, CA 92705	Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
P820003/S074 9/1/99	Model 5388 External Pulse Generator	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for labeling changes for the Model 5388 External Pulse Generator.
P820018/S073* 9/24/99	Version R5.111WE Programmer Software for the Model 9602 Programmer	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.
P830026/S075 9/24/99	Rx5000 Programmer Model 522-12	Guidant Corporation St. Paul, MN 55112-5798	Approval for a manufacturing site located at Benchmark Electronics, 4065 Theurer Blvd., Winona, MN 55987.
P830045/S067* 9/24/99	Model 3264 Rev A Programmer Software for the Model 3250 APSm Programmer	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSm Programmer.
P840008/S069* 9/2/99	Dornier Compact Delta Lithotripter � Stationary, Mobile and Transportable	Dornier Medical Systems, Inc. Kennesaw, GA 30144	Approval for a change that would allow the option of a rotating x-ray anode in addition to the currently available stationary anode.
P850022/S009 9/24/99	SpinalPak Bone Growth Stimulator	Biolectron, Inc. Hackensack, NJ 07601	Approval for SpinalPak Bone Growth Stimulator. The device is indicated as a noninvasive bone growth stimulator for use as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.
P850029/S002* 9/22/99	Abbott ER-EIA Monoclonal	Abbott Laboratories, Abbott Park, IL 60064-6200	Approval for adding "Caution: This Product Contains Natural Dry Rubber" to labeling.
P850049/S007 9/14/99	Gianturco-Roehm Bird�s Nest® Vena Cava Filter	Cook, Inc. Bloomington, IN 47402-0489	Approval to add a Patient Guide booklet to each device shipment.
P860003/S030 9/7/99	THERAKOS UVAR® Photopheresis System using UVADEX®	THERAKOS Exton, PA 19341	Approval for a labeling change to reflect the use of UVADEX®, the sterile liquid formulation of 8-methoxypsoralen (8-mop).
P870078/S005 9/29/99	Hancock I Standard Bioprosthesis Valve, Models 242, 343, 342C, and 342R	Medtronic Heart Valves Santa Ana, CA 92705	Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
P880006/S030* 9/24/99	Model 3264 Rev A Programmer Software for the model 3250 APSm Programmer	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSm Programmer.
P880038/S035* 9/24/99	Version R5.111WE Programmer Software for the Model 9602 Programmer	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.
P880086/S047 9/13/99	Polarity Pulse Generator Models 2091K and 2091M/S	St. Jude Medical Sylmar, CA 91392-9221	Approval for the Polarity Pulse Generator Models 2091K and 2091M/S.
P880086/S068* 9/24/99	Model 3264 Rev A Programmer Software for the Model 3250 APSm Programmer	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Model 3264 rev A programmer software for use with the Model 3250 APSm Programmer.
P890025/S012* 9/29/99	TDx/TDxFLx Cyclosporine and Metabolites Whole Blood and TDx/TDxFLx Cyclosporine Monoclonal Blood	Abbott Laboratories Abbott Park, IL 60064-6200	Approval for adding "Caution: This product contains natural dry rubber" to the labeling.
P890043/S033 9/30/99	Simpson Coronary AtheroCath® SCA-EX™, GTO®, and BANTAM™ Atherectomy Catheters	Guidant Corporation Temecula, CA 92589-9018	Approval for a change in the labeling for the Simpson Coronary AtheroCath® SCA-EX™, GTO®, and BANTAM™ Atherectomy Catheters to 1) include clinical data from the Balloon versus Optimal Atherectomy Trial (BOAT) and 2) streamline the remainder of the text.
P900013/S002* 9/22/99	Abbott PgR-EIA Monoclonal	Abbott Laboratories, Abbott Park, IL 60064-6200	Approval for adding "Caution: This Product Contains Natural Dry Rubber" to the labeling.
P900043/S015 9/14/99	CrossFlex™ LC Balloon Expandable Stent with Over-the-Wire Delivery System	Cordis Corporation Warren, NJ 07059	Approval to market a new stent system. The device is indicated for improving coronary luminal diameter in the following: Patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary arteries (length £ 30 mm) with a reference vessel diameter of 3.0 to 4.0 mm. Long term outcome (beyond 6 months) for this permanent implant is unknown at present.
P900056/S026 9/16/99	RotaGlide™ Lubricant for use with the Rotablator® Rotational Angioplasty System	Boston Scientific Corporation Redmond, WA 98052-3376	Approval for the RotaGlide™ Lubricant.
P900070/S025* 9/24/99	Version R5.111WE Programmer Software for the Model 9602 Programmer	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Version R5.111WE programmer software for the Model 9602 Programmer.
P910023/S045* 9/27/99	Cadence® Tiered Therapy Defibrillator System	St. Jude Medical Sunnyvale, CA 94886-6527	Approval to implement a minor manufacturing change (increase in the number of Kapton layers between the high voltage capacitors) in the Contour and Angstrom implantable defibrillators.
P910065/S001 9/10/99	AIA-PACK PA	Tosoh Medics, Inc. South San Francisco, CA 94080	Approval for the AIA-PACK PA. The device is designed for in vitro diagnostic use only for the quantitative measurement of Prostate Specific Antigen (PSA) in human serum on TOSOH AIA System analyzers. This device is indicated for the measurement of serum PSA in conjunction with Digital Rectal Examination (DRE) as an aid in the detection of prostate cancer (CaP) in men fifty years of age and older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of PSA in human serum to be used as an aid in the management of patients with prostatic cancer.
P910073/S027* 9/29/99	ENDOTAK® DSP, ENTDOTAK® ENDURANCE, ENDOTAK® ENDURANCE Ex, ENDOTAK® ENDURANCE EZ Lead Systems and the Model 6952 Lead Extender	Guidant Corporation St. Paul, MN 55112-5798	Approval for a modified DF-1 terminal of the ENDOTAK® series of Endocardial Defibrillation Leads and the Model 6952 Lead Extender, which consists of a shorter terminal pin, a counter bore in the terminal pin, and a modified coil transition.
P920015/S016 9/24/99	Medtronic® Sprint™ Leads Models 6932, 6937, 6942, 6943 and 6945	Medtronic, Inc. Minneapolis, MN 55432	Approval for adding a caution label to the Medtronic® Sprint™ Lead Models 6932, 6937, 6942, 6943 and 6945.
P920023/S009 9/17/99	UroLume Endoprosthesis	American Medical Systems, Inc. Minnetonka, MN 55343	Approval for a new manufacturing site located at American Medical Systems, 10700 Bren Road West, Minnetonka, MN.
P930014/S006 9/20/99	AcrySof® Single-Piece Foldable Acrylic Posterior Chamber Intraocular Lens (IOL), Model SA30EL	Alcon Laboratories, Inc. Fort Worth, TX 76134	Approval for the AcrySof® Single-Piece Foldable Acrylic Posterior Chamber IOL, Model SA30EL.
P940034/S007 9/2/99	Gen-Probe® Amplified Mycobacterium Tuberculosis Direct Test	Gen-Probe, Inc. San Diego, CA 92121-4362	Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents. The supplement included a protocol for assessing effectiveness of user controls with rRNA controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for P940034/S004.
P940034/S008 9/30/99	Gen-Probe® Amplified™ Mycobacterium Tuberculosis Direct (MTD) Test	Gen-Probe, Inc. San Diego, CA 92121-4362	Approval for the in vitro diagnostic detection of Mycobacterium tuberculosis complex rRNA in aciid-fast bacilli (AFB) smear positive and negative concentrated sediments prepared from sputum (induced or expectorated), bronchial specimens (e.g., bronchoalveolar lavages or bronchial aspirates) or tracheal aspirates. The MTD test is intended for use only with specimens from patients showing signs and symptoms consistent with active pulmonary tuberculosis. MTD is to be used as an adjunctive test for evaluating either AFB smear positive or negative sediments prepared using NALC-NaOH digestion-decontamination of respiratory specimens. Patients who are suspected of having pulmonary TB based on clinical evaluation and who have received no antituberculous therapy, less than 7 days of such therapy, or have not received such therapy in the last 12 months may be evaluated with this test. The MTD test should be performed only in laboratories proficient in the culture and identification of M. tuberculosis (Level II or III or extent 3 and 4). The MTD test must be performed in conjunction with mycobacterial culture.
P950024/S002 9/16/99	CapSureEpi® Model 4968 Steroid-Eluting Bipolar Epicardial Pacing Lead	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a new pacing lead model and is indicated for use with a pulse generator as part of a cardiac pacing system. The lead has application where implantable epicardial atrial or ventricular, single or dual chamber pacing systems are indicated.
P950029/S007* 9/16/99	Brio Cardiac Pacemakers (V5)	ELA Medical, Inc. Plymouth, MN 55441	Approval for the introduction of version 5 of the Brio pacemakers, including the introduction of the dedicated bipolar Model 222.
P960001/S006 9/20/99	DePuy 2 Bone Cement (Fast Set Bone Cement)	DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988	Approval for a change in the bone cement formulation to alter the handling characteristics.
P960001/S008 9/1/99	DePuy 1 and Endurance Bone Cements	DePuy Orthopaedics, Inc. Warsaw, IN 46581-0988	Approval for minor labeling changes: 1) change the package insert labeling for DePuy 1 Bone Cement from multilingual to English only; and 2) change to the package labeling for DePuy 1 and Endurance Bone Cements to remove reference to pack sizes that are approved but not currently marketed.
P960004/S008 9/27/99	ThinLine™ and FINELINE™ Endocardial Pacemaker Leads	Guidant Corporation St. Paul, MN 55112-5798	Approval for the alternate manufacturing facility located at Guidant Puerto Rico, No. 12 Road No. 698, Dorado, Puerto Rico 00646 and the alternate sterilization facility located at COSMED of Illinois, 1160 Northpoint Blvd., Waukegan, Illinois 60085.
P960009/S003* 9/30/99	Model 3389 DBS™ Lead for Medtronic Activa Tremor Control System	Medtronic, Inc., Neurological Division Minneapolis, MN 55421-1200	Approval for the Model 3389 DBS™ Lead (as an alternative tot he existing Model 3387 DBS™ Lead) for use in conjunction with the existing Medtronic Activa Tremor Control System.
P960043/S020 9/16/99	Techstar® XL Percutaneous Vascular Surgical (PVS) System	Perclose, Inc. Redwood City, CA 94063	Approval for modifications to the manufacture and quality control of the Techstar® XL PVS System.
P970004/S005* 9/3/99	Medtronic® Interstim® System for Urinary Control (Medtronic® Model 3057 Temporary Test Stimulation Lead)	Medtronic®, Inc. Minneapolis, MN 55421	Approval for an alternate insulation material for the Medtronic® Model 3057 Temporary Test Stimulation Lead.
P970007/S001* 9/22/99	Abbott IMx Tacrolimus II	Abbott Laboratories, Abbott Park, IL 60064-6200	Approval for adding "Caution: This Product Contains Natural Dry Rubbber" to the labeling.
P970024/S003 9/14/99	Angeion Sentinel™ Implantable Cardioverter/Defibrillator (ICD) System	Angeion Corporation Minneapolis, MN 55428-1088	Approval for removal of patient monitoring for the capacitor part number 200068-106 of the post-approval requirement.
P970029/S001 9/17/99	Eclipse TMR Holmium Laser System	Eclipse Surgical Technologies Sunnyvale, CA 94089	Approval for a proposed post-approval study protocol. In addition, all advertising and promotional materials must include the warning about the use of TMR in a patient with unstable angina, the need for patients to sign a consent form and the requirements that apply to the training of practitioners who may use the device.
P970031/S009 9/29/99	Medtronic Freestyle Aortic Root Bioprosthesis	Medtronic Heart Valves Santa Ana, CA 92705	Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, Santa Ana, CA.
P970043/S001 9/24/99	LADARVision® Excimer Laser System	Autonomous Technologies Corporation Orlando, FL 32826	Approval for the inclusion of labeling claims in the Patient Information Booklet, Physician's Booklet, and System Operation Manual regarding the effectiveness of the eye tracker component of the LADARVision® Excimer Laser System when used for the approved indication. Other requested modifications to the labeling included updates to data tables in the Physician's Booklet, and editorial changes and revised operational procedures in the System Operation Manual.
P970043/S004* 9/24/99	LADAR Vision® Excimer Laser System	Autonomous Technologies, Corporation Orlando, FL 32826	Approval for adding software computer screens to provide precautions when refractive parameters were entered that were outside the approved indications for use. These indications for use remain: PRK for the reduction or elimination of -1.00 to -10.00 D of spherical myopia with or without -1.00 to -4.00 D of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0.50 and -10.00 D SE at the spectacle plane where sphere or cylinder magnitude is at least 1.00 D.
P970053/S001 9/29/99	Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism	Nidek Technologies, Inc. Pasadena, CA 91105	Approval for the Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism. This device is intended for use in: 1) the reduction or elimination of myopia with astigmatism ranging in severity from -1.00 to -8.00 diopters (D), in terms of manifest refraction spherical equivalent (MRSE), with refractive astigmatism ranging in severity from -0.5 to -4.00 D cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion. A nomogram lookup table is provided for specific treatment combinations. 2) patients who have a stable history of both pretreatment myopic astigmatism (i.e., magnitude of change in manifest refraction of £ 0.5D per year in terms of MRSE for at least one year proceeding treatment) and pretreatment astigmatism (i.e., a magnitude of change of £ 0.5D per year in cylinder for at least one year preceding treatment); and 3) patients who are over 21 years of age.
P970058/S004 9/2/99	ImageChecker M1000	R2 Technology, Inc. Los Altos, CA 94022	Approval for new software that places circle markers around correlated mass markers.
P970061/S007 9/17/99**	SCIMED® RADIUS Coronary Stent	Scimed Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for the addition of a centerless grinding process to widen trace element nitinol tubing material.
P980015/S003* 9/17/99	Sharp_x™ Needle Destruction Unit	Biomedical Disposal, Inc. Norcross, GA 30092	Approval for a modification of a contraindication statement in the labeling.
P980023/S002* 9/13/99	mycroPhylax^Plus, Phylax XM, and TMS 1000^Plus Tachyarrhythmia Monitoring System	Biotronik, Inc. Lake Oswego, OR 97035-5369	Approval for device hardware and software modifications. The devices are indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyarrhythmias; or recurrent poorly tolerated sustained ventricular tachycardia (VT).

30-DAY NOTICES
APPLICATION NUMBER & LTR DATE	DEVICE NAME	COMPANY NAME	COMMENTS
P880091/S017* 9/2/99**	STAAR Surgical Elastic UVA PC Intraocular Lens (IOL)	STAAR Surgical Company, Inc. Monrovia, CA 91016	The 30-Day Notice requested that STAAR Surgical Company be permitted to implement a Gentinge Castle Autoclave to sterilize products during the scheduled or unscheduled shutdown of the primary autoclave manufactured by Kuhlman Technologies, Inc.
P900052/S008* 9/23/99**	Port-A-Cath® Epidural Implantable Access System; Port-A-Cath® II Epidural Low Profile™ Implantable Access System		The 30-day Notice requested a manufacturing process change for the Port-A-Cath® Epidural Implantable Access System and for the Port-A-Cath® II Epidural Low Profile™ Implantable Access System. This change would allow the use of an automated turbidometric assay method for determination of pyrogens using the LAL-5000 System with PYROS Software.
P930038/S021* 9/10/99**	8F Angio-Seal™ Hemostatic Puncture Closure Device	Daig Corporation Minnetonka, MN 55345	The 30-Day Notice requested a change from 10 weeks to 24 weeks as the maximum duration time between the molding date of the anchor and the sterilization date of the finished device that includes the anchor.
P950032/S015* 9/28/99**	Apligraft® (Graftskin)	Organogenesis, Inc. Canton, MA 02021	The 30-day Notice requested a manufacturing process change. The requested change will place into the manufacturing process the final 3 production-scale incubators manufactured by Lunaire Corporation (model # CI0641W-6SPL).
P950034/S013* 9/3/99**	Seprafilm® Bioresorbable Membrane	Genzyme Corporation Cambridge, MA 02139-1562	The 30-Day Notice requested a manufacturing process change for Seprafilm® Bioresorbable Membrane. The requested change would allow the use of a new Urania Heat Sealer, Model 3500-P, to seal the foil pouches containing Seprafilm®.
P960011/S003* 9/2/99**	BioLon™ (1% sodium hyaluronate) For Ophthalmic Surgery	Bio-Technology General Corporation Iselin, NJ 08830	The 30-Day Notice requested a manufacturing process change for BioLon™ (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade.

*Real-Time Supplement
**135 Day Supplement
***30 Day Notice (135 Day Supplement Was Not Required)

Summary of PMA Originals & Supplements Approved
Originals: 10
Supplements: 51

Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 44
Total On Hold: 35
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 228
Total Active: 158
Total On Hold: 70
Number Greater Than 180 Days: 0

Summary of All PMA Submissions Received
Originals: 3
Supplements: 64

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 140
FDA Time: 101 Days MFR Time: 39 Days

Updated 7/23/2001

horizonal rule

Center for Devices and Radiological Health / CDRH