Medical Devices
November 1996 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for November 1996. 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
|
Approval Date |
Trade Name |
Applicant Name, City, State, & Zip Code |
Description of Device and Indication |
|
11/07/96 |
Maxim™PFS Model 033-301 Pacing Lead |
Englewood, CO 80112 |
The device is intended for chronic pacing and sensing of the ventricle when used with a compatible pulse generator. |
|
11/26/96 |
AMPLICOR® Mycobacterium Tuberculosis Test |
Roche Molecular Systems, Inc. |
This device is a target amplified in vitro diagnostic test for the qualitative detection of M. tuberculosis complex DNA in concentrated sediments prepared from sputum (induced or expectorate), bronchial specimens including bronchoalveolar lavages or aspirates, or tracheal aspirates. The AMPLICOR MTB Test is intended for use as an adjunctive test for evaluating acid fast bacilli (AFB) smear positive sediments prepared using NALC-NaOH or NaOH digestion-decontamination of respiratory specimens from untreated patients suspected of having tuberculosis. Untreated patients are patients who have: (1) received no antituberculosis therapy, (2) had less than 7 days of therapy, or (3) have not received such therapy in the last twelve months. Only untreated patients may be evaluated with this test. The AMPLICOR MTB Test should only be performed in institutions proficient in the culture and identification of M. tuberculosis (ATS Level II and III or CAP extent 3 and 4. The test should always be performed in conjuncting with mycobacterial culture. |
|
11/12/96 |
ThinLine™ Models 430-10 and 432-04 Endocardial Pacing Leads |
Angleton, TX 77515 |
These devices are indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator. |
|
11/15/96 |
LaserVision®/VISX Excimer Laser System Model C for Phototherapeutic Keratectomy (PTK) and Photorefractive Keratectomy (PRK) |
St. Louis, MO 63141 |
1) PTK in patients with decreased best corrected visual acuity and/or with disabling pain that are the result of superficial corneal epithelial irregularities or stromal scars in the anterior one-third of the cornea. The patients must have failed with alternative treatment options. For safety, the immediate postoperative corneal thickness must not be less than 250 microns. Examples of those conditions that warrant PTK are: a) corneal scars and opacity (from trauma and inactive infections), b) dystrophies (Reis-Buckler's, granular and lattice), c) Thygeson's superficial keratitis, d) irregular corneal surfaces associated with filamentary keratitis and Salzmann's nodular degeneration, e) residual band keratopathy after unsuccessful EDTA treatment, and, f) scars subsequent to previous (not concurrent) pterygium excision. 2)PRK for a 6.0 ablation zone in patients who are myopic and meet all of the following criteria: a) 1.0 to 6.0 diopters (D) of myopia with astigmatism of £ 1.0 diopters; b) refractive change is within ± 0.5 D for one year prior to the laser treatment; and c) 18 years of age or older. The stationary LaserVision®/VISX Excimer Laser System Model C for PRK will only be enabled either through the use of the VisionKey™ Card or the software controls in the device to treat simple myopia (no astigmatism) -1.0 to -6.0 D. |
PMA Supplement Approvals
|
Approval Date |
Trade Name |
Applicant Name, City, State, & Zip Code |
Description of Device and Indication |
|
11/15/96 |
OrthoGEN®/OsteoGEN™ Implantable Bone Growth Stimulator |
A Subsidiary of Biomet, Inc. Parsippany, NJ 07054-1079 |
Approval for the transfer of the test analysis for the device from Caribbean Bioresearch Laboratories and Geneva Laboratories to Electro-Biology, Inc., in Guaynabo, Puerto Rico. |
|
11/21/96 |
PERMAFLEX® NATURALS (surfilcon A) and PERMAFLEX® UV NATURALS (vasurfilcon A) HYDROPHILIC CONTACT LENSES for Daily and Extended Wear |
Scottsvile, MY 14546 |
Approval for changes to the labeling of the devices to combine the Professional Fitting Guide, Instructions for Wear Booklet, and Package Insert. |
|
11/05/96 |
ACS RX STREAK™ Coronary Dilatation Catheter ACS RX FLOWTRACK™ Coronary Dilatation Catheter |
Advanced Cardiovascular Systems, Inc. Temecula, CA 92591-4628 |
Approval for the addition of new product names to allow concurrent distribution by a second company. The devices, as modified, will be marketed under the trade names ACS RX GAZELLE™ Coronary Dilatation Catheter and ACS RX FlexFlo™ Coronary Dilatation Catheter, 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. |
|
11/18/96 |
ACS RX COMET™ Coronary Dilatation Catheter |
Advanced Cardiovascular Systems Santa Clara, CA 95052-8167 |
Approval for the ACS RX COMET™ Coronary Dilatation Catheter. |
|
11/21/96 |
OPTI-ZYME® Enzymatic Cleaner |
Fort Worth, TX 76134-2099 |
Approval for use of OPTI-ONE® Multi-Purpose Solution as a diluent for OPTI-ZYME® Enzymatic Cleaner Tablets. |
|
11/21/96 |
Biotronic Gemnos 04 and Gemnos TC 04 Cardiac Pacemakers |
Lake Oswego, OR 97035 |
Approval for the use of your self-sealing header and spring contractor, which replaces your current header design utilizing separable setscrews and sealing caps. The device, as modified, will be marketed under the same trade names, the Gemnos 04 and Gemnos TC 04 Cardiac Pacemakers. |
|
11/21/96 |
OPTI-ONE® Multi-Purpose Solution |
Alcon Laboratories, Inc. |
Approval for the use of OPTI-ONE® Multi-Purpose Solution as a diluent for OPTI-ZYME® Enzymatic Cleaner Tablets. |
|
11/19/96 |
Model 3203a Function Pack for use with the APS II Programmer |
A St. Jude Medical Company Sylmar, CA 91392-9221 |
Approval for the Model 3203a Function pack for use with the APS II Programmer. |
|
11/12/96 |
Cardiac Pacemakers (CPI) St. Paul, MN 55112 |
Approval for an alternate sterilization facility located at Cosmed of Illinois, 1160 Northpoint Blvd., Waukegan, IL 60085. |
|
|
11/05/96 |
Dornier Compact S Lithotripter |
Kennesaw, GA 30144 |
Approval for the following design modifications: I) the use of the Performa ultrasound imaging system, (ii) addition of x-ray imaging, and (iii) minor design changes. The device, as modified, will be marketed under the trade name Dornier Compact S Lithtripter and is indicated for the fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelvic stones. |
|
11/15/96 |
MAXON AND MAXON CV POLYGLYCONATE MONOFILAMENT ABSORBABLE SUTURE |
St. Louis, MS 63103-1642 |
Approval of a new supplier of Trimethylene Carbonate. |
|
11/07/96 |
Recorder/Monitor (PRM); Model 2909 (Version 2.0), and Model 2880 (Version 2.3) |
St. Paul, MN 55112-5798 |
Approval for (1) a new programming system, the Model 2901 PRM programming system with the commercially available VIGOR® family of pulse generators and accessories, and (2) a new manufacturing contract facility, emd Associates, Inc., (EMD), 4065 Theurer Blvd., Winona, MN 55987. |
|
11/12/96 |
Delta Pacemaker System |
Cardiac Pacemakers (CPI) St. Paul, MN 55112 |
|
|
11/15/96 |
SpF® Implantable Spinal Fusion Stimulator |
A Subsidiary of Biomet, Inc. Parsippany, NJ 07054-1079 |
Approval for the transfer of the test analysis for the device from Caribbean Bioresearch Laboratories and Geneva Laboratories to Electro-Biology, Inc., in Guaynabo, Puerto Rico. |
|
11/08/96 |
OCUCOAT® (2% Hydroxypropylmethylcellulose Solution) |
Clearwater, FL 34619 |
Approval for an extension of the shelf life for OCUCOAT® from 18 months to two years. |
|
11/13/96 |
Sorbic Acid Preserved Saline Solution for Soft Contact Lenses |
Fairton, NJ 08320-0210 |
Approval to market the device in a 16 fl. oz. container size. |
|
11/18/96 |
Medstone STS® Lithotripter |
Medstone International, Inc. |
Approval for use of the physician's reference guide entitled "Physician's Reference Guide for the Medstone STS® Shockwave Therapy System." |
|
11/07/96 |
Valor and Valor XL PTCA Dilatation Catheters |
Miami, FL 33102-5700 |
Approval for quarter-size balloons on the Valor and Valor XL PTCA Dilatation Catheters which are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
|
11/20/96 |
Valor and Valor XL PTCA Dilatation Catheters |
Miami, FL 33102-5700 |
Approval for Valor and Valor XL PTCA Dilatation Catheters with 10mm and 15mm balloon lengths. These catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
|
11/14/96 |
Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses (IOLS) |
Monrovia, CA 91016 |
Approval for the addition of an alternate steam sterilizer and reverse osmosis unit to your sterilization process. |
|
11/19/96 |
Preva ST DR Model 7078 and Preva D Model 7068 Pulse Generators; and the Model 9959 Software |
Minneapolis, MN 55432-3576 |
Approval to commercially distribute the Medtronic Preva ST DR Model 7078 and Preva D Model 7068 Pulse Generators; and the Model 9959 Software. |
|
11/18/96 |
AtheroCath-Bantam™ Directional Coronary Atherectomy System |
Devices for Vascualr Intervention Santa Clara, CA 95052-8167 |
Approval for the AtheroCath-Bantam™ DCS System. |
|
11/26/96 |
USCI® Probe™ III Balloon-On-A-Wire™ Dilatation System |
C.R. Bard, Inc. Billerica, MA 01821 |
Approval for a modification to the package tray of the USCI® Probe™ III Balloon-On-A-Wire™ Dilatation System. |
|
11/12/96 |
Ventak P AICD System |
Cardiac Pacemakers (CPI) St. Paul, MN 55112 |
Approval for an alternate sterilization facility located at Cosmed of Illinois, 1160 Northpoint Blvd., Waukegan, IL 60085. |
|
11/08/96 |
Medtronic® Model 7218 B/C/D/E with the Model 9896 Software and the Medtronic® Model 7223Cx Micro Jewel II™ with Model 5705 Active Can Emulator and Model 9955 Software |
Minneapolis, MN 55432-3576 |
Approval for Medtronic® Model 7218 B/C/D/E with the Model 9896 Software and the Medtronic® Model 7223Cx Micro Jewel II™ with Mdoel 5705 Active Can Emulator and Model 9955 Software. |
|
11/27/96 |
Meta™ DDDR Pulse Generator Model 1254 |
Englewood, CO 80112 |
Approval for a modification to the labeling regarding the proper insertion of a lead into the connector port. |
|
11/08/96 |
Cadet™ High-Voltage Can ICD Models V-105AC and V-115AC, Cadet™ Test Can Model AC-CDT-TCN, Cadet™ Test Cable Model AC-CDT-TCB, Contour™ Test Can Model AC-TCN and Contour™ Test Cable Model AC-TCB |
Sunnyvale, CA 94086-6527 |
Approval for the Cadet™ High-Voltage Can ICD Models V-105AC and V-115AC, Cadet™ Test Can Model AC-CDT-TCN, Cadet™ Test Cable Model AC-CDT-TCB, Contour™ Test Can Model AC-TCN and Contour™ Test Cable Model AC-TCB. |
P910073/S21 |
Endotak Lead System |
Cardiac Pacemakers (CPI) St. Paul, MN 55112 |
Approval for an alternate sterilization facility located at Cosmed of Illinois, 1160 Northpoint Blvd., Waukegan, IL 60085. |
|
11/07/96 |
Recorder/Monitor (PRM); Model 2872 (Version 5.1), Model 2840 (Version 2.1), and Model 2909 (Version 2.0) |
St. Paul, MN 55112-5798 |
Approval for (1) a new programming system, the Model 2901 PRM programming system with the commercially available Ventak® PRxII/PRxIII, MINI pulse generators and accessories, and (2) a new manufacturing contract facility, emd Associates, Inc., (EMD), 4065 Theurer Blvd., Winona, MN 55987. |
|
11/18/96 |
VENTAK Model 2840 Software Application, Version 2.2 |
St. Paul, MN 55112 |
Approval for Model 2840, Software Application, Version 2.2 which is a modification of Version 2.1. |
|
11/12/96 |
Ventak Prx AICD System |
Cardiac Pacemakers (CPI) St. Paul, MN 55112 |
Approval for an alternate sterilization facility located at Cosmed of Illinois, 1160 Northpoint Blvd., Waukegan, IL 60085. |
|
11/18/96 |
PAS Champion™ Catheter 30 mm long balloons |
Menlo Park, CA 94025 |
Approval for the following balloon sizes to be added to the PAS Champion™ PTCA Catheter line: 2.5mm x 30mm; 3.0mm x 30mm; and 3.5mm x 30mm. |
|
11/07/96 |
VISX Excimer Laser System Models "B" and "C" |
Santa Clara, CA 95051-0703 |
1. a protocol for a prospective postapproval study to detect rare but serious adverse events; and, 2. changes to update the Phase III PRK protocol for postapproval follow-up purposes. |
|
11/25/96 |
SVS Apex (formerly OmniMed) Excimer Laser System |
Waltham, MA 02154 |
Approval for the request that FDA cancel the post approval requirement that a mesopic contrast senvitivity and glare study be performed. |
P930035/S7 |
Ventak P2 AICD System |
Cardiac Pacemakers (CPI) St. Paul, MN 55112 |
Approval for an alternate sterilization facility located at Cosmed of Illinois, 1160 Northpoint Blvd., Waukegan, IL 60085. |
|
11/07/96 |
Model 2901 Programmer/Recorder/Monitor (PRM); Model 2909 (Version 2.0), and Model 2880 (Version 2.3) |
St. Paul, MN 55112-5798 |
Approval for (1) a new programming system, the Model 2901 PRM programming system with the commercially available VIGOR® family of pulse generators and accessories, and (2) a new manufacturing contract facility, emd Associates, Inc., (EMD), 4065 Theurer Blvd., Winona, MN 55987. |
|
11/12/96 |
Vigor DR/SR Pacemaker System |
Cardiac Pacemakers (CPI) St. Paul, MN 55112 |
Approval for an alternate sterilization facility located at Cosmed of Illinois, 1160 Northpoint Blvd., Waukegan, IL 60085. |
|
11/12/96 |
Selute Steroid Eluting Pacing Lead |
Cardiac Pacemakers (CPI) St. Paul, MN 55112 |
Approval for an alternate sterilization facility located at Cosmed of Illinois, 1160 Northpoint Blvd., Waukegan, IL 60085. |
|
11/22/96 |
Prostatron |
Cambridge, MA 02139 |
Approval for the addition of a precautionary statement to the labeling regarding the steps that should be taken in the event of Prostaprobe balloon deflation difficulty. |
|
11/07/96 |
Seprafilm™ Bioresorbable Membrane |
Cambridge, MA 02139-1562 |
Approval for a change in the current HA/CMC specification for the urea assay from the current 3-15% to a specification of 10-18% for the modified assay. The supplement is also approved for the replacement of the USP Rabbit Pyrogen Assay with the Limulus Amoebocyte Lysate (LAL) assay as the standard pyrogen test. |
|
11/06/96 |
ThinPrep® 2000 System |
Boxborough, MA 01719 |
Approval for new labeling including statistical analysis of the data. |
Errata for PMA Original Approvals
|
Approval Date |
Trade Name |
Applicant Name, City, State, & Zip Code |
Description of Device and Indication |
|
10/02/96 |
Emit® 2000 Cyclosporine Specific Assay |
San Jose, CA 95161-9013 |
MIRA S, and COBAS MIRA Plus chemistry systems for the quantitative analysis of cyclosporine (CsA) in human whole blood as an aid in the management of cyclosporine therapy in kidney, heart, and liver transplant patients. |