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PMA Final Decisions Rendered for October 1997 |
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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.
| APPLICATION NUMBER/ DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| P970020
10/2/97 |
ACS Multi-Link™ Coronary Stent System | Guidant Corporation/Advance Cardiovascular
Systems
Santa Clara, CA 95052-8167 |
Approval for the ACS Multi-Link™ Coronary Stent System |
| APPLICATION NUMBER/ DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION/ INDICATIONS |
|---|---|---|---|
| N16895/S085
10/15/97 |
Bausch & Lomb Optima™ FW (polymacon) Visibility Tinted Contact Lens | Bausch & Lomb
Rochester, NY 14692 |
Approval for labeling modifications: 1) combination of the separate package insert and professional fitting guide into a single package insert and fitting guide; and 2) incorporation of information in the package insert and fitting guide related to prescribing the lenses for frequent replacement and disposable wear, along with separate patient information booklets for disposable and frequent replacement wear. |
| N17755/S048
10/28/97 |
Osteobond Copolymer Bone Cement | Zimmer
Warsaw, IN 46581-0708 |
Approval for a change in the gamma sterilization method of the Osteobond Copolymer Bone Cement powder component. |
| P810002/S044
10/20/97 |
St. Jude Medical® Mechanical Heart Valve Pulmonic Valved Graft (PVG) Prosthesis, model PVG-201 Coated Aortic Valved Graft (CAVG) Prosthesis, model CAVG-404 | St. Jude Medical, Inc.
St. Paul, MN 55117 |
Approval for the termination of the PVG and CAVG postapproval studies. These studies were required by the supplement 3 and supplement 27 approval letter dated March 1, 1984, and February 10, 1997, respectively. |
| P810055/S068
10/22/97 |
Extended Power Range for CeeOn™ Posterior Chamber Intraocular Lens Model 812B | Pharmacia & Upjohn Company
Pickerington, OH 43147 |
Approval to extend the dioptric power range of Model 812B to -10D to +40D. The device is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoing a primary lens implantation, in either the ciliary sulcus or capsular bag following an extracapsular cataract extraction. |
| P820049/S062
10/7/97 |
Posterior Chamber Polymethylmethacrylate (PMMA) Intraocular Lenses (IOLs) | Allergan, Inc.
Irvine, CA 92612-9534 |
Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 µg/lens." |
| P820049/S064
10/2/97 |
Model PC-10 Posterior Chamber Polymethylmethacrylate (PMMA) Intraocular Lens (IOL) | Allergan Medical Optics
Irvine, CA 92612-9534 |
Approval for alternate sterilization parameters for the 100% ethylene oxide (EO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, Puerto Rico. |
| P820060/S012
10/29/97 |
Abbott Imx AFP Assay | Abbott Laboratories
Abbott Park, IL 60064 |
Approval for changes in the labeling regarding limitations of the procedures. |
| P830045/S054
10/7/97 |
APS III Model 3500 Programmer with Model 3302 Software | Pacesetter, Inc.
A St. Jude Medical Company Sylmar, CA 91392-9221 |
Approval for the APS III Model 3500 Programmer with Model 3302 Software. |
| P840002/S007
10/3/97 |
TapSystem 2A | Seecor, Inc.
Mesquite, TX 75149 |
Approval for a manufacturing site located at Haller Industries, Inc. 4895 West Waters, Suite J, Tampa, Florida. |
| P860019/S130
10/31/97 |
SCIMED® NC Ranger™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | SCIMED Life Systems, Inc.
Maple Grove, MN 55311-1566 |
Approval for additional balloon sizes (22, 25, and 30 mm balloon lengths with balloon diameters ranging from 2.5 to 4.0 mm in 0.25 mm increments) for the NC Ranger™ PTCA Catheter. |
| P860019/S133
10/31/97 |
Scimed® Jaz Ranger PTCA Catheter | Scimed
Boston Scientific Corporation Scimed Life Systems, Inc. Maple Grove, MN 55311-1566 |
Additional manufacturing site located at Boston Scientific Ireland and the sterilization facility at Isotron Ireland, Ltd. |
| P860022/S048
10/15/97 |
BOSTON EQUALENS (itafluorofocon A) and EQUALENS II (oprifocon A) Rigid Gas Permeable Contact Lenses | Polymer Technology, Corporation
Rochester, NY 14692 |
Approval for the five additional finishing laboratories listed in the enclosure to become additional manufacturers and distributors of the contact lenses. FDA also acknowledges your notification of a new adopted USAN name for EQUALENS II (oprifocon A). |
| P860034/S013
10/7/97 |
Anterior Chamber PMMA IOLs | Allergan, Inc.
Irvine, CA 92612-9534 |
Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 µg/lens." |
| P860034/S015
10/2/97 |
Models AC-21 and AC-21B Anterior Chamber IOLs | Allergan Medical Optics
Irvine, CA 92612-9534 |
Approval for alternate sterilization parameters for the 100% ethylene oxide (EO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, P.R. |
| P870015/S027
10/31/97 |
Medstone STS Lithotripter | Medstone International, Inc.
Aliso Viejo, CA 92656-4114 |
Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report). |
| P870050/S007
10/15/97 |
Sereine Contact Lens Cleaner and Sereine Contact Lens Wetting and Soaking Solution | Wilsa, 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/S007
10/15/97 |
Sereine Contact Lens Cleaner and Sereine Contact Lens Wetting and Soaking Solution | Wilsa, Inc.
Denver, CO 80223 |
Approval for an expansion of the indicatiosn for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses. |
| P880027/S048
10/9/97 |
Bonnie™ Sliding Rail 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 Bonnie™ Sliding Rail Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters 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/S050
10/23/97 |
Bonnie™ Monorail® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Schneider (USA), Inc.
Plymouth, MN 55442 |
Approval for 15 mm length models of the Bonnie™ PTCA Catheter. The new models will be marketed under the trade name Bonnie™ Monorail® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters 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. |
| P880027/S051
10/23/97 |
Bonnie™ Monorail® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter | Schneider (USA), Inc.
Plymouth, MN 55442 |
Approval for 30 and 40 mm length models of the Bonnie™ PTCA Catheter. The new models will be marketed under the trade name Bonnie™ Monorail® Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters and are indicated for balloon dilatation for the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |
| P880081/S019
10/7/97 |
Ultraviolet-Absorbing Silicone Posterior Chamber IOLs | Allergan Medical Optics
Irvine, CA 92612-9534 |
Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 µg/lens." |
| P880081/S023
10/2/97 |
Models SI-18B and SI-18NB Ultraviolet-Absorbing Silicone Posterior Chamber IOLs | Medical Optics Allergan
Irvine, CA 92612-9534 |
Approval for alternate sterilization parameters for the 100% ethylene oxide (EO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas, P.R. |
| P880086/S041
10/7/97 |
APS III Model 3500 Programmer with Model 3302 Software | Pacesetter, Inc.
A St. Jude Medical Company Sylmar, CA 91392-9221 |
Approval for the APS III Model 3500 Programmer with Model 3302 Software. |
| P890056/S003
10/7/97 |
Posterior Chamber PMMA IOLs | Allergan Medical Optics
Irvine, CA 92612-9534 |
Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 µg/lens." |
| P890056/S005
10/2/97 |
Model PC-28LB Posterior Chamber PMMA IOL | Medical Optics Allergan
Irvine, CA 92612-9534 |
Approval for alternate sterilization parameters for the 100% ethylene oxide (EO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salinas |
| P900070/S020
10/7/97 |
META™ DDDR Model 1256D Cardiac Pulse Generator | Pacesetter, Inc.
Sylmar, CA 91342 |
Approval for the change in companies from Telectronics to Pacesetter. The device, as modified, will be marketed under the brand name Pacesetter for the dual chamber pacing models of the META™ DDDR Model 1250H Pulse Generator (hereinafter referred to as the META™ (DDDR) which is indicated where maintenance of atrio-ventricular synchrony is required. This requirement is associated with the generally accepted indication for permanent cardiac pacing which includes, but are not limited to: 1) sick sinus node syndrome; 2)symptomatic bradycardia; 3)symptomatic A-V block; 4)recurrent Stokes-Adams syndrome; 5)carotid sinus syncope; and 6)suppression of tachycardia. |
| P900070/S021
10/16/97 |
TEMPO Pulse Generators (TEMPO DR Model 2102, TEMPO D Model 2902, TEMPO VR Model 1102, and TEMPO V Model 1902) | Pacesetter, Inc.
Sylmar, CA 91342-3577 |
Approval for an alternate manufacturing facility located at Pacesetter, Inc., St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. |
| P910061/S001
10/21/97 |
SOFLEX Models LI51U and LI61U Ultraviolet-Absorbing Silicone Posterior Chamber Intraocular Lenses (IOLs) | Chiron Vision Corporation
Claremont, CA 91711 |
Approval for the Models LI51U and LI61U IOLs. |
| P920051/S007
10/31/97 |
Storz MODULITH® Lithotripter, Models SL-20 and SLX | Karl Storz Endoscopy-America, Inc.
Culver City, CA 90230-7600 |
Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report). |
| P940002/S002
10/16/97 |
Natural Knee® and Natural Knee® II with CSTi™ | Sulzermedica
Austin, TX 78717 |
Approval for another sterilization site located at SteriGenics International, 3125 Wichita Court, Fort Worth, Texas 76140. |
| P940034/S006
10/30/97 |
Gen-Probe® Amplified Mycobacterium tuberculosis Direct Test | Gen-Probe, Inc.
San Diego, CA 92121-4361 |
Approval for manufacturing facility relocation to 10210 Genetic Center Dr., San Diego, CA. |
| P950002/S003
10/15/97 |
BAK Interbody Fusion System | Spine-Tech, Inc.
Minneapolis, MN 55439-2029 |
Approval for the BAK/RLP (Reduced Lateral Profile) implant configuration of the BAK Interbody Fusion System. |
| P950014/S007
10/27/97 |
Prostatron | EDAP Technomed, Inc.
Burlington, MA 01803 |
Approval for a single-module version of the Prostatron, as well as minor hardware and software changes to both the single and dual-module Prostatron versions. |
| P950014/S010
10/7/97 |
Prostatron | EDAP Technomed, Inc.
Burlington, MA 01803 |
Approval for a transmobile version for the Prostatron (dual module version). |
| P950039/S004
10/8/97 |
ThinPrep® 2000 System | CYTYC Corporation
Boxborough, MA 01749 |
Approval for use of PreservCyt Solution as an alternative collection and transport medium for gynecologic specimens tested with the Digene Hybrid Capture System HPV DNA Assay. |
| P960004/S002
10/23/97 |
ThinLine™ Models 430-10 and 432-04 Endocardial Pacing Leads and ThinLine™ EZ Model 438-10 Active Fixation Endocardial Pacing Lead | Sulzer Intermedics
Angleton, TX 77515-2523 |
Approval for the use of an alternate tubing extrusion process for the Pellethane® 55D used in the ThinLine™ family of pacing leads. |
| P960007/S001
10/17/97 |
Dermagraft-TC | Advanced Tissue Sciences
La Jolla, CA 92037-1005 |
Approval for the new indication of partial thickness burns that are mid- dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. |
| P960028/S001
10/7/97 |
Model SA-40N AMO® Array® Multifocal Ultraviolet-Absorbing Silicone Posterior Chamber IOL | Allergan, Inc.
Irvine, CA 92612-9534 |
Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 µg/lens." |
| P970003/S002
10/9/97 |
NeuroCybernetic Prosthesis (NCP®) System | Cyberonics, Inc.
Webster, TX 77598-4135 |
Approval for the modified NCP® System Lead Connector Boot Design and the NCP® System Programming Software Version 4.1. |
| P970003/S005
10/9/97 |
NeuroCybernetic Prosthesis (NCP®) System | Cyberonics, Inc.
Webster, TX 77598-4135 |
Approval for the modified NCP® System Lead Connector Boot Design and the NCP® System Programming Software Version 4.1. |
| P970004/S001
10/31/97 |
Medtronic® Interstim® Sacral Nerve Stimulation (SNS)™ System (Medtronic® Model 041826 Self-Adhesive Ground Pad Bulk Accessory) | Medtronic, Inc.
Interstim Venture Minneapolis, MN 55432-3576 |
Approval for the Medtronic® Model 041826 Self-Adhesive Ground Pad Bulk Accessory. |
| P970008/S003
10/28/97 |
Urologix Targis™ System | Urologix
Minneapolis, MN 55447 |
Approval for the addition of a capacitor to the circuitry leading to each of the five sensors withing the rectal thermosensing unit (RTU) of the Targis™ System to improve the accuracy of the RTU temperature readings. |
Updated 12/2/1998
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