Medical Devices
November 1997 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for November 1997. 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 |
|---|---|---|---|
|
11/24/97 |
Toronto SPV® Valve, Model SPA-101 |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for the Toronto SPV® Valve, Model SPA-101, sizes 21, 23, 25, 27, and 29 mm and the Toronto SPV® Valve Sizer Set, Model 300SPA. The device is a tissue heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves. |
|
11/26/97 |
Medtronic FREESTYLE® Aortic Root Bioprosthesis, Model 995 |
Medtronic Heart Valves Irvine, CA 92714 |
Approval for the Medtronic FREESTYLE® Aortic Root Bioprosthesis, Model 995; sizes 19, 21, 23, 25, 27 mm; implantation techniques, subcoronary, full-root, and root inclusion; and the FREESTYLE® Aortic Obturators, Model 7990 and the Medtronic Handle, Model 0791. This device is a replacement heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. |
PMA Supplement Approvals
| APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
|
*N17004/S010 11/13/97 |
Surgical Simplex®P Radiopaque Bone Cement |
Howmedica Inc. Rutherford, NJ 07070-2584 |
Approval for the elimination of a series of duplicative tests that are performed on the Surgical Simplex® P Bone Cement. |
|
P790018/S031 11/24/97 |
Medtronic Hall Prosthetic Heart Valve (Models A7700 and M7700) |
Medtronic Heart Valves, Inc. Irvine, CA 92714 |
Approval for a modification to the controlled environment area for certain manufacturing steps. |
|
P810037/S007 11/25/97 |
MicroGas |
Kontron Instruments Ltd. United Kingdom |
Approval for modification of MicroGas 7640 with COMBI 81. The device, as modified, will be marketed under the trade name MicroGas 7650 with COMBI M82. |
|
P810046/S179 11/7/97 |
ACS RX Rocket and ACS Avenger Coronary Dilatation Catheters |
Guidant Corporation Advanced Cardiovascular Systems Santa Clara, CA 95052-8167 |
Approval for the ACS RX Rocket and ACS Avenger Coronary Dilatation Catheters. The device is indicated for: 1)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; and 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with S-T segment elevation myocardial infarction. |
|
P810046/S181 11/26/97 |
ACS Tx2000VP Coronary Balloon Dilatation Catheter |
Guidant Corporation Santa Clara, CA 95052-8167 |
Approval for the ACS Tx2000VP coronary dilatation catheter with additional balloon sizes 2.75, 3.25, and 3.75 x 15 mm and 20 mm. |
|
P840008/S061 11/3/97 |
Dornier Lithotripter |
Dornier Medical Systems, Inc. Kennesaw, GA 30144 |
Approval to offer the Dornier X-ray Imaging Module, the Extended Image Stoarage component, and an alternative electrocardiogram monitor as options for your device. In addition, the Advance Technology Laboratories ultrasound system will no longer be an option on your device. Finally, the wording of your precaution on hypertension has been modified as requested by FDA after our review of your postapproval study results. |
|
P840040/S051 11/21/97 |
Boston Scientific Corporation® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
SCIMED Life Systems, Inc. Maple Grove, MN 55311-1566 |
Approval for a change in adhesive. |
|
P850051/S054 11/18/97 |
Prevail Pacemaker |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for cell phone labeling for the Prevail, Preva, Prodigy, Thera-i, and Vitatron pacemakers. |
|
*P850089/S037 11/21/97 |
Model 5023M CapSure® SP Pacing Lead |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for a change in connector design for the Model 5023M pacing lead. |
|
P860040/S014 11/4/97 |
BIOCURVE SOFT FLEXIBLE WEAR (methafilcon A) CONTACT LENS (Clear and Handling Tinted Hydrophilic Contact Lenses) |
Cal Bionics Novato, CA 94947 |
Approval for adding a visibility tint to the contact lens and revised labeling for the spherical lens to reflect the addition of the visibility tint. There are no changes in the previously approved indications for use. |
|
P880003/S068 11/18/97 |
Cordis THOR PTCA Dilatation Catheters |
Cordis Corporation Miami, FL 33102-5700 |
Approval for an additional marker band on the 10 mm balloon length of the THOR PTCA Dilatation Catheters. |
|
P880011/S009 11/6/97 |
Sonolith 3000 Lithotripter |
EDAP Technomed, Inc. Burlington, MA 01803 |
Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report). |
|
P880027/S049 11/10/97 |
Takumi Over the Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters |
Schneider (USA), Inc. Plymouth, MN 55442 |
Approval for a new model PTCA catheter. The device, as modified, will be marketed under the trade name Takumi Over the Wire Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
|
P880027/S053 11/21/97 |
Bonnie Sliding Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters |
Schneider (USA), Inc. Minneapolis, MN 55442 |
Approval for a 3-year shelf life for the Bonnie Sliding Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. |
|
P890003/S051 11/18/97 |
Preva, Prodigy, Thera-i, and Vitatron Pacemakers |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for cell phone labeling for the Prevail, Preva, Prodigy, Thera-i, and Vitatron pacemakers. |
|
P900061/S034 11/26/97 |
Medtronic® Implantable Cardioverter Defibrillator Models 7219, 7220, 7221, and 7223 |
Medtronic, Inc. Minneapolis, MN 55432-3576 |
Approval for the addition of silicone gel over the internal surfaces of the Fast Recovery Diode in the Medtronic® Implantable Cardioverter Defibrillator Models 7219, 7220, 7221, and 7223. |
|
P910020/S018 11/18/97 |
Relay Model 294-03E |
Sulzer Intermedics, Inc. Angleton, TX 77515-2523 |
Approval for the Relay Model 294-03E edgeband pulse generator. |
|
P910023/S031 11/5/97 |
Ventritex Tiered Therapy Defibrillator System |
St. Jude Medical, Inc. Cardiac Rhythm Management Division Sunnyvale, CA 94086-6527 |
Approval of the Ventritex Cadence® and Cadet® with the Medtronic Transvene® defibrillation leads. |
|
P910031/S017 11/10/97 |
LYNX Coronary Balloon Dilatation Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Guardian Coronary Balloon Dilatation PTCA Catheter |
CardioVascular Dynamics, Inc. Irvine, CA 92618 |
Approval for a change in the trade name from the LYNX to the Guardian Coronary Balloon Dilatation PTCA Catheter. |
|
*P910073/S023 11/17/97 |
ENDOTAK® DSP Endocardial Defibrillation Lead Models 0095 and 0125 |
Guidant Corporation Cardiac Pacemakers (CPI) St. Paul, MN 55112-5798 |
Approval for changes to the IS-1 terminal of the DSP lead. |
|
P930038/S009 11/17/97 |
Angio-Seal Hemostatic Puncture Closure Device |
Quinton Instrument Company Bothell, WA 98021-8906 |
Approval for changes to the Information Card and Patient Brochure. |
|
*P940008/S007 11/21/97 |
Res-Q Micron ICD Models 101-09 and 101-05 |
Sulzer Intermedics, Inc. Angleton, TX 77515-2523 |
Approval for an alternate battery. |
|
P950014/S006 11/24/97 |
Prostatron® TUMT 2.5 Treatment Protocol |
EDAP Technomed, Inc. Burlington, MA 01803 |
Approval for changes to the Prostatron® software program to include a high energy treatment protocol (using either the single or dual-module hardware configurations).
|
|
P950014/S008 11/7/97 |
Prostatron |
EDAP Technomed, Inc. Burlington, MA 01803 |
Approval for a new sterilization facility located at Griffith Micro Science, 8 rue de Parmentier, 60290 Rantigny, France. |
|
P960001/S001 11/12/97 |
DePuy 1 Bone Cement (Endurance, New Formulation) |
DePuy, Inc. Warsaw, IN 46581-0988 |
Approval for new PMMA/MMA-Styrene co-polymer formulation. The device, as modified, will be marketed under the trade Endurace Bone Cement and is indicated for the fixation of prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty. |
|
P960007/S003 11/24/97 |
Dermagraft-TC |
Advanced Tissue Sciences, Inc. La Jolla, CA 92037-1005 |
Approval for a change of Dermagraft-TC storage conditions to include -20C frost-free freezers. |
|
P960043/S001 11/5/97 |
Techstar 6 French Percutaneous Vascular Surgical (PVS) System and Techstar XL 6 French PVS System |
Perclose, Inc. Menlo Park, CA 94025 |
Approval for modified Percutaneous Vascular Surgical devices. The devices, as modified, will be marketed under the trade names Techstar 6 French Percutaneous Vascular Surgical (PVS) System and Techstar XL 6 French PVS System and are indicated for the percutaneous delivery of sutures for closing the common femoral artery access site of patients who have undergone diagnostic catheterization procedures using 5 to 6 French sheaths. |
|
P960043/S003 11/18/97 |
Prostar® Percutaneous Vascular Surgical (PVS) System |
Perclose, Inc. Menlo Park, CA 94025 |
Approval for changes to the Precautions and Clinical Procedure sections of the Instructions for Use. |
|
P970003/S003 11/21/97 |
NeuroCybernetic (NCP®) Prosthesis System |
Cyberonics, Inc. Webster, TX 77598-4135 |
Approval for the Model 250 NCP Software Version 5.0 modification. |
|
*P970008/S004 11/26/97 |
Urologix Targis System |
Urologix Minneapolis, MN 55447 |
Approval for a change to the physician training manual for the addition of a module for patient comfort management. |
|
*P970019/S001 11/10/97 |
LithoTron Lithotripsy System |
HealthTronics Marietta, GA 30067 |
Approval to offer the HealthTronics LithoTron Lithotripsy System in both a mobile and transportable version. |
*Evaluated as a "Real-Time Review" PMA Supplement.