Medical Devices
July 1997 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 1997. This list is generated on a monthly basis.
PMA Original Approvals
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
|
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. |
|
7/31/97 |
Medtronic® 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. |
|
7/18/97 |
VENTAK® 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. |
|
7/16/97 |
NeuroCybernetic Prosthesis (NCP®) 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. |
|
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. |
PMA Supplement Approvals
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
|
N18033/S31 7/11/97 |
ACUVUE® (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 ACUVUE® 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 |
SpF® 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 SpF® Implantable Spinal Fusion Stimulator product line (SpF®-2T, SpF®-4T, SpF®-XL, and the SpF®XL II) and the OsteoGen Implantable Spinal Fusion Stimulator product line. |
|
P790019/S10 7/24/97 |
HAVAB® - 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-FREE® SUPRACLENS® 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-FREE® SUPRACLENS® Daily Protein Remover. |
|
P820001/S23 7/3/97 |
OPTI-FREE® SUPRACLENS® 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-ONE® 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-FREE® SUPRACLENS® 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 |
SpF® 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 SpF® Implantable Spinal Fusion Stimulator product line (SpF®-2T, SpF®-4T, SpF®-XL, and the SpF®XL 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 |
ULTRACARE® 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 |
SCIMED® NC BIG Ranger Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for the SCIMED® NC BIG Ranger PTCA Catheter. |
| P860019/S124 | SCIMED® 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 |
Medtronic® 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 Medtronic® 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 |
Thoratec® 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 |
Contigen® Bard® Collagen Implant |
Collagen Corporation Palo Alto, CA 94303-3308 |
Approval for a labeling change. |
|
P900061/S33 7/2/97 |
Medtronic® 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 |
ContaClair® 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 ContaClair® 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 |
Medtronic® Sprint Model 6942 Lead |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for the Medtronic® 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 |
Hyalgan® |
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. |