PMA Final Decisions Rendered for November 1997

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PMA Final Decisions Rendered for November 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 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
P970030 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.
P970031 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.

APPLICATION NUMBER/
DATE of APPROVAL

DEVICE
TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION/ INDICATIONS

P970030

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.

P970031

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.

Updated 12/2/1998

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Center for Devices and Radiological Health / CDRH