PMA Final Decisions Rendered for July 1997

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 July 1997. This list is generated on a monthly basis.

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
P940024 7/3/97	Guardian ATP II Model 4211 Implantable Cardioverter/ Defibrillator System	Telectronics Pacing System Englewood, CO 80112	The device is indicated for use in patients who are at high risk of sudden death due to ventricular fibrillation and/or ventricular tachyrhythmias and who have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyrhthmia; 2) recurrent, poorly tolerated sustained ventricular tachycardia (VT). Note: The clinical outcome for hemodynamically stable, sustained-VT patients is not fully known. Safety and effectiveness studies have not been conducted.
P960009 7/31/97	MedtronicŽ Activa Tremor Control System	Medtronic, Inc. Neurological Division Neurostimulation Business Minneapolis, MN 55440-9087	The device is indicated for unilateral thalamic stimulation for the suppression of tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.
P960040 7/18/97	VENTAKŽ AV AICD Model 1810/Model 1815 Automatic Implantable Cardioverter Defibrillator (AICD) with the Model 2833 Software Application	Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798	The device is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained ventricular tachycardia (VT); prior myocardial infarction, left ventricular ejection fraction of 35 percent, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia. Patients suppressible with IV procainamide or an equivalent antiarrhythmic have not been studied.
P970003 7/16/97	NeuroCybernetic Prosthesis (NCPŽ) System	Cyberonics, Inc. Webster, TX 77598-4135	This device is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to anti-epileptic medications.
P970019 7/21/97	LithoTron Lithtripsy System	HealthTronics, Inc. Marietta, GA 30067	This device is indicated for use in patients with renal and upper ureteral calculi between 4 and 20 mm in size.

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

P940024

7/3/97

Guardian ATP II Model 4211 Implantable Cardioverter/

Defibrillator System

Telectronics Pacing System

Englewood, CO

80112

The device is indicated for use in patients who are at high risk of sudden death due to ventricular fibrillation and/or ventricular tachyrhythmias and who have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyrhthmia; 2) recurrent, poorly tolerated sustained ventricular tachycardia (VT). Note: The clinical outcome for hemodynamically stable, sustained-VT patients is not fully known. Safety and effectiveness studies have not been conducted.

P960009

7/31/97

MedtronicŽ Activa Tremor Control System

Medtronic, Inc.

Neurological Division

Neurostimulation Business

Minneapolis, MN

55440-9087

The device is indicated for unilateral thalamic stimulation for the suppression of tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.

P960040

7/18/97

VENTAKŽ AV AICD Model 1810/Model 1815 Automatic Implantable Cardioverter Defibrillator (AICD) with the Model 2833 Software Application

Guidant Corporation

Cardiac Pacemakers (CPI)

St. Paul, MN

55112-5798

The device is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced one of the following situations: survival of at least one episode of cardiac arrest (manifested by loss of consciousness) due to a ventricular tachyarrhythmia; recurrent, poorly tolerated sustained ventricular tachycardia (VT); prior myocardial infarction, left ventricular ejection fraction of 35 percent, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia. Patients suppressible with IV procainamide or an equivalent antiarrhythmic have not been studied.

P970003

7/16/97

NeuroCybernetic Prosthesis (NCPŽ) System

Cyberonics, Inc.

Webster, TX

77598-4135

This device is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to anti-epileptic medications.

P970019

7/21/97

LithoTron Lithtripsy System

HealthTronics, Inc.

Marietta, GA

30067

This device is indicated for use in patients with renal and upper ureteral calculi between 4 and 20 mm in size.

APPLICATION NUMBER/ DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION/ INDICATIONS
N18033/S31 7/11/97	ACUVUEŽ (etafilcon A) Contact Lens Clear and Visibility Tint with UV Blocker	Vistakon, Johnson and Johnson Vision Products, Inc. Jacksonville, FL 32247	Approval for changes in the Package Insert and Fitting and Patient Management Guide pertaining to the ACUVUEŽ BIFOCAL (etafilcon A) Contact Lens. The changes are designed to enhance practitioners' fitting performance and early visual success of the patient. No changes are made to the remaining portions of approved labeling.
P790005/S39 7/17/97	SpFŽ Implantable Spinal Fusion Stimulator and OsteoGen Implantable Spinal Fusion Stimulator	Electro-Biology, Inc. Parsippany, NJ 07054	Approval for the Model ST-72 Implant Tester for use with the SpFŽ Implantable Spinal Fusion Stimulator product line (SpFŽ-2T, SpFŽ-4T, SpFŽ-XL, and the SpFŽXL II) and the OsteoGen Implantable Spinal Fusion Stimulator product line.
P790019/S10 7/24/97	HAVABŽ - M EIA	Abbott Laboratories Abbott Park, IL 60064	Approval for a change in the evaluation of the HAVAB-M EIA Conjugate Concentrate, Positive Control from a sample to standard ratio to a sample to target ratio.
P810046/S175 7/3/97	ACS RX LIFESTREAM Coronary Dilatation Catheter	Guidant Corporation Advanced Cardiovascular Systems Santa Clara, CA 95052	Approval for an alternate method of sterilization for the ACS RX LIFESTREAM Coronary Dilatation Catheter.
P810046/S176 7/17/97	ACS RX LIFESTREAM Coronary Dilatation Catheter	Guidant Corporation Advanced Cardiovascular Systems Santa Clara, CA 95052	Approval for ACS RX LIFESTREAM Coronary Dilatation Catheter with 4.5 mm and 5.0 mm balloon diameters by 15 mm, 20 mm and 30 mm balloon lengths.
P820001/S22 7/2/97	OPTI-FREEŽ SUPRACLENSŽ Daily Protein Remover	Alcon Laboratories, Inc. Fort Worth, TX 76134-2099	Approval to allow for the use of Alcon Multi-Purpose Solution ID 81573 (OPTI-ONE Multi-Purpose Solution) as an alternate diluent for OPTI-FREEŽ SUPRACLENSŽ Daily Protein Remover.
P820001/S23 7/3/97	OPTI-FREEŽ SUPRACLENSŽ Daily Protein Remover	Alcon Laboratories, Inc. Fort Worth, TX 76134-2099	Approval for a 1.5 ml fill volume in the same container as the currently approved 3.0 ml fill size.
P830034/S34 7/2/97	Alcon Multi-Purpose Solution ID 81573 (OPTI-ONEŽ Multi-Purpose Solution)	Alcon Laboratories, Inc. Fort Worth, TX 76134-2099	Approval to allow for the use of Alcon Multi-Purpose Solution ID 81573 (OPTI-ONE Multi-Purpose Solution) as an alternate diluent for OPTI-FREEŽ SUPRACLENSŽ Daily Protein Remover.
P840069/S7 7/2/97	Charter Saline Solution, Sensitive Eyes Formulation	Paco Pharmaceutical Services, Inc. Lakewood, NJ 08701	Approval for relocation of the Griffith MicroScience sterilization site to 27 Park Rd., Glens Falls, NY.
P850035/S21 7/17/97	SpFŽ Implantable Spinal Fusion Stimulator and OsteoGen Implantable Spinal Fusion Stimulator	Electro-Biology, Inc. Parsippany, NJ 07054	Approval for the Model ST-72 Implant Tester for use with the SpFŽ Implantable Spinal Fusion Stimulator product line (SpFŽ-2T, SpFŽ-4T, SpFŽ-XL, and the SpFŽXL II) and the OsteoGen Implantable Spinal Fusion Stimulator product line.
P850070/S10 7/2/97	Sterile Preserved Saline Solution	Automatic Liquid Packaging, Inc. Woodstock, IL 60098-7498	Approval to eliminate ethylene oxide sterilization of the flip-top piercing cap attached to sealed 12 oz. and 16 oz. containers of Sterile Preserved Saline Solution.
P850075/S9 7/2/97	Sorbic Acid Preserved Lens Lubricant	Paco Pharmaceutical Services, Inc. Lakewood, NJ 08701	Approval for relocation of the Griffith MicroScience sterilization site to 27 Park Rd., Glens Falls, NY.
P850076/S9 7/2/97	Sorbic Acid Preserved Cleaning Solution	Paco Pharmaceutical Services, Inc. Lakewood, NJ 08701	Approval for relocation of the Griffith MicroScience sterilization site to 27 Park Rd., Glens Falls, NY.
P850088/S36 7/3/97	ULTRACAREŽ Neutralizing Tablets With Color Indicator	Allergan Optical Irvine, CA 92623-9534	Approval for an alternate formulation using catalase raw material derived from a non-animal source and an associated change in the minimum neutralization soak time from 2 to 4 hours. The alternate formulation includes no changes in the indications for use.
P860004/S36 7/17/97	Medtronic SynchroMed Infusion System	Medtronic Neurological Minneapolis, MN 55440	Approval for the use of an alternative bead blasted shield surface finish along with an associated change to the laser engraving for the Medtronic SynchroMed pump's titanium shields. The bead blasted shield finish, and associated continuous laser power engraving process, may serve as an alternative to the current straight line shield finish in that either finish may be used on the device.
P860019/S123 7/15/97	SCIMEDŽ NC BIG Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for the SCIMEDŽ NC BIG Ranger PTCA Catheter.
P860019/S124	SCIMEDŽ Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter	SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566	Approval for a change from 1 to 2 marker bands for the 20 mm balloon length Ranger PTCA Catheter and for a change that makes all Ranger PTCA Catheter (20, 30, and 40 mm balloon lengths) marker band locations proximal and distal.
P860023/S12 7/3/97	BAUSCH & LOMB ReNu Multi-Purpose Solution	Bausch & Lomb Rochester, NY 14692-0450	Approval for a change in the formulation and corresponding modifications to the labeling. The device as modified, will be marketed under the trade name BAUSH & LOMB ReNu MultiPlus Multi-Purpose Solution and is indicated for use in the daily cleaning, promotion of daily protein removal, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.
P860027/S12 7/29/97	Maestro II Model 534 Pacemaker System	Cardiac Control Systems, Inc. Palm Coast, FL 32164-3100	Approval for the Maestro II Model 534 Pacemaker System.
P870036/S42 7/28/97	MedtronicŽ Folio Balloon Shaping Tool	Medtronic Interventional Vascular San Diego, CA 92121-2256	Approval for the addition of an accessory device, the Folio Balloon Shaping Tool, to the currently marketed line of MedtronicŽ Millenia Coronary Balloon Dilatation Catheters.
P870050/S6 7/2/97	Sereine Contact Lens Cleaner and Sereine Contact Lens Wetting and Soaking Solution	Wilsa, Inc. Optikem International, Inc. Denver, CO 80223	Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
P870051/S6 7/2/97	Sereine Contact Lens Cleaner and Sereine Contact Lens Wetting and Soaking Solution	Wilsa, Inc. Optikem International, Inc. Denver, CO 80223	Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
P870072/S4 7/10/97	ThoratecŽ Ventricular Assist Device (VAD) System	Thoratec Laboratories Corporation Berkeley, CA 94710	Approval for changing the test methodology for measuring molecular weight of BPS-215 from gel permeation chromatography to intrinsic viscosity during the manufacturing process.
P880003/S69 7/18/97	Charger PTCA Dilatation Catheters	Cordis Corporation Miami Lakes, FL 33102-5700	Approval for the Cordis Charger family of PTCA Dilatation Catheters.
P890057/S9 7/8/97	Model 3100A High Frequency Oscillatory Ventilator	Critical Care Products SensorMedics Corporation Yorba Linda, CA 92887-4645	Approval for a change in the manufacturing of the patient circuit to Ultrasonic welding.
P900030/S6 7/11/97	ContigenŽ BardŽ Collagen Implant	Collagen Corporation Palo Alto, CA 94303-3308	Approval for a labeling change.
P900061/S33 7/2/97	MedtronicŽ Model 7223Cx Micro Jewel II	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for a modification of the Cx Connector Module for the Model 7223 Micro Jewel II.
P910020/S19 7/29/97	Momentum Pacers, Models 294-23, 294-23Z, and 293-23	Sulzer Intermedics, Inc. Angleton, TX 77515	Approval for the Momentum Pulse Generator Models 294-23, 294-23Z, and 293-23 with the Rx5000 Programmer Model 522-12 with Marathon Application Software Version 3.00.
P910023/S26 7/1/97	Contour Implantable Cardioverter Defibrillator System	Ventritex, Inc. Sunnyvale, Ca 94086-6527	Approval of the "C" header configuration for the Contour Implantable Cardioverter Defibrillator System.
P910074/S1 7/3/97	ContaClairŽ Multi-Purpose Solution	Eurexpan Labo Washington, DC 20036	Approval for expanding the indications for use of the device to include use with silicone/acrylate and fluorosilicone/acrylate rigid gas permeable (RGP) contact lenses. When used with RGP lenses, the device will be marketed under the trade name ContaClairŽ RGP Multi-Purpose Solution, and is indicated for use in cleaning, rinsing, disinfecting and storing daily and extended wear RGP contact lenses.
P920015/S12 7/18/97	MedtronicŽ Sprint Model 6942 Lead	Medtronic, Inc. Minneapolis, MN 55432-3576	Approval for the MedtronicŽ Sprint Model 6942 Lead System.
P930029/S8 7/29/97	5 French RF Marinr Catheter	Medtronic CardioRhythm Sunnyvale, CA 94089-1113	Approval for the 5 French RF Marinr Catheter.
P930038/S6 7/28/97	Angio-Seal* Hemostatic Puncture Closure Device	Quinton Instrument Company Bothell, WA 98021-8906	Approval for expanding the range of device users to include health care professionals other than physicians.
P950002/S1 7/22/97	BAK Interbody Fusion system	Spine-Tech, Inc. Minneapolis, MN 55439-2029	Approval to include the laparoscopic surgical approach in the labeling for the BAK Interbody Fusion System
P950027/S1 7/8/97	HyalganŽ	FIDIA Pharmaceutical Corporation Washington, D.C. 20006	Approval for the U.S. distributor, Sanofi Pharmaceuticals, Inc., New York, New York. Additionally, the editorial changes proposed have been reviewed and determined to be appropriate.
P960024/S1 7/3/97	Unizyme Enzymatic Cleaner	Ciba Vision Corporation Duluth, GA 30155-1518	Approval for addition of Ciba Vision's SOLOCare Brand Multi-Purpose Solution to the labeling of the Unizyme Enzymatic Cleaner as a diluent to be used sequentially with the Unizyme enzyme.

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

N18033/S31

7/11/97

ACUVUEŽ (etafilcon A) Contact Lens Clear and Visibility Tint with UV Blocker

Vistakon, Johnson and Johnson Vision Products, Inc.

Jacksonville, FL

32247

Approval for changes in the Package Insert and Fitting and Patient Management Guide pertaining to the ACUVUEŽ BIFOCAL (etafilcon A) Contact Lens. The changes are designed to enhance practitioners' fitting performance and early visual success of the patient. No changes are made to the remaining portions of approved labeling.

P790005/S39

7/17/97

SpFŽ Implantable Spinal Fusion Stimulator and OsteoGen Implantable Spinal Fusion Stimulator

Electro-Biology, Inc.

Parsippany, NJ

07054

Approval for the Model ST-72 Implant Tester for use with the SpFŽ Implantable Spinal Fusion Stimulator product line (SpFŽ-2T, SpFŽ-4T, SpFŽ-XL, and the SpFŽXL II) and the OsteoGen Implantable Spinal Fusion Stimulator product line.

P790019/S10

7/24/97

HAVABŽ - M EIA

Abbott Laboratories

Abbott Park, IL

60064

Approval for a change in the evaluation of the HAVAB-M EIA Conjugate Concentrate, Positive Control from a sample to standard ratio to a sample to target ratio.

P810046/S175

7/3/97

ACS RX LIFESTREAM Coronary Dilatation Catheter

Guidant Corporation

Advanced Cardiovascular Systems

Santa Clara, CA

95052

Approval for an alternate method of sterilization for the ACS RX LIFESTREAM Coronary Dilatation Catheter.

P810046/S176

7/17/97

ACS RX LIFESTREAM Coronary Dilatation Catheter

Guidant Corporation

Advanced Cardiovascular Systems

Santa Clara, CA

95052

Approval for ACS RX LIFESTREAM Coronary Dilatation Catheter with 4.5 mm and 5.0 mm balloon diameters by 15 mm, 20 mm and 30 mm balloon lengths.

P820001/S22

7/2/97

OPTI-FREEŽ SUPRACLENSŽ Daily Protein Remover

Alcon Laboratories, Inc.

Fort Worth, TX

76134-2099

Approval to allow for the use of Alcon Multi-Purpose Solution ID 81573 (OPTI-ONE Multi-Purpose Solution) as an alternate diluent for OPTI-FREEŽ SUPRACLENSŽ Daily Protein Remover.

P820001/S23

7/3/97

OPTI-FREEŽ SUPRACLENSŽ Daily Protein Remover

Alcon Laboratories, Inc.

Fort Worth, TX

76134-2099

Approval for a 1.5 ml fill volume in the same container as the currently approved 3.0 ml fill size.

P830034/S34

7/2/97

Alcon Multi-Purpose Solution ID 81573 (OPTI-ONEŽ Multi-Purpose Solution)

Alcon Laboratories, Inc.

Fort Worth, TX

76134-2099

Approval to allow for the use of Alcon Multi-Purpose Solution ID 81573 (OPTI-ONE Multi-Purpose Solution) as an alternate diluent for OPTI-FREEŽ SUPRACLENSŽ Daily Protein Remover.

P840069/S7

7/2/97

Charter Saline Solution, Sensitive Eyes Formulation

Paco Pharmaceutical Services, Inc.

Lakewood, NJ

08701

Approval for relocation of the Griffith MicroScience sterilization site to 27 Park Rd., Glens Falls, NY.

P850035/S21

7/17/97

SpFŽ Implantable Spinal Fusion Stimulator and OsteoGen Implantable Spinal Fusion Stimulator

Electro-Biology, Inc.

Parsippany, NJ

07054

P850070/S10

7/2/97

Sterile Preserved Saline Solution

Automatic Liquid Packaging, Inc.

Woodstock, IL

60098-7498

Approval to eliminate ethylene oxide sterilization of the flip-top piercing cap attached to sealed 12 oz. and 16 oz. containers of Sterile Preserved Saline Solution.

P850075/S9

7/2/97

Sorbic Acid Preserved Lens Lubricant

Paco Pharmaceutical Services, Inc.

Lakewood, NJ

08701

Approval for relocation of the Griffith MicroScience sterilization site to 27 Park Rd., Glens Falls, NY.

P850076/S9

7/2/97

Sorbic Acid Preserved Cleaning Solution

Paco Pharmaceutical Services, Inc.

Lakewood, NJ

08701

Approval for relocation of the Griffith MicroScience sterilization site to 27 Park Rd., Glens Falls, NY.

P850088/S36

7/3/97

ULTRACAREŽ Neutralizing Tablets With Color Indicator

Allergan Optical

Irvine, CA

92623-9534

Approval for an alternate formulation using catalase raw material derived from a non-animal source and an associated change in the minimum neutralization soak time from 2 to 4 hours. The alternate formulation includes no changes in the indications for use.

P860004/S36

7/17/97

Medtronic SynchroMed Infusion System

Medtronic Neurological

Minneapolis, MN

55440

Approval for the use of an alternative bead blasted shield surface finish along with an associated change to the laser engraving for the Medtronic SynchroMed pump's titanium shields. The bead blasted shield finish, and associated continuous laser power engraving process, may serve as an alternative to the current straight line shield finish in that either finish may be used on the device.

P860019/S123

7/15/97

SCIMEDŽ NC BIG Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

SCIMED Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for the SCIMEDŽ NC BIG Ranger PTCA Catheter.

P860019/S124

SCIMEDŽ Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

SCIMED Life Systems, Inc.

Maple Grove, MN

55311-1566

Approval for a change from 1 to 2 marker bands for the 20 mm balloon length Ranger PTCA Catheter and for a change that makes all Ranger PTCA Catheter (20, 30, and 40 mm balloon lengths) marker band locations proximal and distal.

P860023/S12

7/3/97

BAUSCH & LOMB ReNu Multi-Purpose Solution

Bausch & Lomb

Rochester, NY

14692-0450

Approval for a change in the formulation and corresponding modifications to the labeling. The device as modified, will be marketed under the trade name BAUSH & LOMB ReNu MultiPlus Multi-Purpose Solution and is indicated for use in the daily cleaning, promotion of daily protein removal, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by the eye care practitioner.

P860027/S12

7/29/97

Maestro II Model 534 Pacemaker System

Cardiac Control Systems, Inc.

Palm Coast, FL

32164-3100

Approval for the Maestro II Model 534 Pacemaker System.

P870036/S42

7/28/97

MedtronicŽ Folio Balloon Shaping Tool

Medtronic Interventional Vascular

San Diego, CA

92121-2256

Approval for the addition of an accessory device, the Folio Balloon Shaping Tool, to the currently marketed line of MedtronicŽ Millenia Coronary Balloon Dilatation Catheters.

P870050/S6

7/2/97

Sereine Contact Lens Cleaner and Sereine Contact Lens Wetting and Soaking Solution

Wilsa, Inc.

Optikem International, Inc.

Denver, CO

80223

Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.

P870051/S6

7/2/97

Sereine Contact Lens Cleaner and Sereine Contact Lens Wetting and Soaking Solution

Wilsa, Inc.

Optikem International, Inc.

Denver, CO

80223

Approval for an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.

P870072/S4

7/10/97

ThoratecŽ Ventricular Assist Device (VAD) System

Thoratec Laboratories Corporation

Berkeley, CA

94710

Approval for changing the test methodology for measuring molecular weight of BPS-215 from gel permeation chromatography to intrinsic viscosity during the manufacturing process.

P880003/S69

7/18/97

Charger PTCA Dilatation Catheters

Cordis Corporation

Miami Lakes, FL

33102-5700

Approval for the Cordis Charger family of PTCA Dilatation Catheters.

P890057/S9

7/8/97

Model 3100A High Frequency Oscillatory Ventilator

Critical Care Products

SensorMedics Corporation

Yorba Linda, CA

92887-4645

Approval for a change in the manufacturing of the patient circuit to Ultrasonic welding.

P900030/S6

7/11/97

ContigenŽ BardŽ Collagen Implant

Collagen Corporation

Palo Alto, CA

94303-3308

Approval for a labeling change.

P900061/S33

7/2/97

MedtronicŽ Model 7223Cx Micro Jewel II

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for a modification of the Cx Connector Module for the Model 7223 Micro Jewel II.

P910020/S19

7/29/97

Momentum Pacers, Models 294-23, 294-23Z, and 293-23

Sulzer Intermedics, Inc.

Angleton, TX

77515

Approval for the Momentum Pulse Generator Models 294-23, 294-23Z, and 293-23 with the Rx5000 Programmer Model 522-12 with Marathon Application Software Version 3.00.

P910023/S26

7/1/97

Contour Implantable Cardioverter Defibrillator System

Ventritex, Inc.

Sunnyvale, Ca

94086-6527

Approval of the "C" header configuration for the Contour Implantable Cardioverter Defibrillator System.

P910074/S1

7/3/97

ContaClairŽ Multi-Purpose Solution

Eurexpan Labo

Washington, DC

20036

Approval for expanding the indications for use of the device to include use with silicone/acrylate and fluorosilicone/acrylate rigid gas permeable (RGP) contact lenses. When used with RGP lenses, the device will be marketed under the trade name ContaClairŽ RGP Multi-Purpose Solution, and is indicated for use in cleaning, rinsing, disinfecting and storing daily and extended wear RGP contact lenses.

P920015/S12

7/18/97

MedtronicŽ Sprint Model 6942 Lead

Medtronic, Inc.

Minneapolis, MN

55432-3576

Approval for the MedtronicŽ Sprint Model 6942 Lead System.

P930029/S8

7/29/97

5 French RF Marinr Catheter

Medtronic CardioRhythm

Sunnyvale, CA

94089-1113

Approval for the 5 French RF Marinr Catheter.

P930038/S6

7/28/97

Angio-Seal* Hemostatic Puncture Closure Device

Quinton Instrument Company

Bothell, WA

98021-8906

Approval for expanding the range of device users to include health care professionals other than physicians.

P950002/S1

7/22/97

BAK Interbody Fusion system

Spine-Tech, Inc.

Minneapolis, MN

55439-2029

Approval to include the laparoscopic surgical approach in the labeling for the BAK Interbody Fusion System

P950027/S1

7/8/97

HyalganŽ

FIDIA Pharmaceutical Corporation

Washington, D.C.

20006

Approval for the U.S. distributor, Sanofi Pharmaceuticals, Inc., New York, New York. Additionally, the editorial changes proposed have been reviewed and determined to be appropriate.

P960024/S1

7/3/97

Unizyme Enzymatic Cleaner

Ciba Vision Corporation

Duluth, GA

30155-1518

Approval for addition of Ciba Vision's SOLOCare Brand Multi-Purpose Solution to the labeling of the Unizyme Enzymatic Cleaner as a diluent to be used sequentially with the Unizyme enzyme.

PMA Final Decisions Rendered for July 1997

PMA Original Approvals

PMA Supplement Approvals