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PMA Final Decisions Rendered for August 1996 |
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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.
P940036 BARTELS BARTELS PROGNOSTICS, AN IN VITRO 08/01/96 CHEMORESPONSE INC. DIAGNOSTIC DEVICE ASSAY ISSAQUAH, WA INTENDED FOR USE TO 98027 DETERMINE RESISTANCE TO 5-FLUOROURACIL (5-FU) OF CELLS ISOLATED FROM BREAST TUMORS WHICH WILL ASSIST PHYSICIANS IN DETERMINING IF 5-FU IS AN INEFFECTIVE TREATMENT FOR RELAPSED BREAST CANCER PATIENTS P950034 SEPRAFILM GENZYME CORP. THE DEVICE IS 08/12/96 BIORESORBABLE INDICATED FOR USE MEMBRANE CAMBRIDGE, MA IN PATIENTS 02139-1562 UNDERGOING ABDOMINAL OR PELVIC LAPAROTOMY AS AN ADJUNCT INTENDED TO REDUCE THE INCIDENCE, EXTENT, AND SEVERITY OF POSTOPERATIVE ADHESIONS BETWEEN THE ABDOMINAL WALL AND THE UNDERLYING VISCERA P960020 RELIANCE URINARY UROMED CORP. THE DEVICE IS 08/16/96 CONTROL INSERT INDICATED FOR THE AND SIZING DEVICE NEEDHAM, MA MANAGEMENT OF STRESS 02194 URINARY INCONTINENCE IN ADULT WOMEN
N50510/S069 VITEK GENERAL BIOMERIEUX VITEK, REMOVAL OF 08/07/96 SUSCEPTIBILITY INC. LIMITATION FOR CARD HAZELWOOD, MO SUSCEPTIBILITY 63042-2395 TESTING OF ENTEROCOCCI/ VANCOMYCIN TESTING ON THE DEVICE P790018/S027 MEDTRONIC-HALL MEDTRONIC, INC. TRANSFER OF SEWING 08/19/96 PROSTHETIC HEART RING FABRICATION AND VALVE, MODELS IRVINE, CA ATTACHMENT, AND A7700 AND M7700 92714 STERILE PACKAGING MANUFACTURING PROCESSES FROM THE MINNEAPOLIS, MN, FACILITY TO THE IRVINE, CA, FACILITY P830026/S067 COSMOS/NOVA/QUANT INTERMEDICS, INC. APPROVAL FOR THE USE 08/19/96 UM/SUPRIMA/PULSE OF AN ALTERNATE GENERATORS ANGLETON, TX CONDUCTIVE EPOXY AND 77515 A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS P830061/S026 MEDTRONIC MEDTRONIC, INC. ALTERNATE PACKAGING 08/12/96 PACING LEADS DESIGN MINNEAPOLIS, MN 55432-3576 P830056/S077 POSTERIOR CHAMBER MENTOR OPTHALMICS APPROVAL FOR A 08/01/96 INTRAOCULAR MANUFACTURING SITE LENSES SANTA BARBARA, CA LOCATED AT CIDRA, 93111 PR 00639 P830063/S001 GAMBRO AB GAMBRO, INC. CHANGE OF MATERIAL 08/28/96 PLASMAFILTER USED IN THE HOUSING PF 2000N AND LAKEWOOD, CO OF THE DEVICE, END EXCORIM KB MAXO 80215 CAP CONFIGURATION PLASMAFILTER MODIFICATION, AND SPECIFICATION CHANGES TO THE DEVICE MEMBRANE P840024/S066 NUCLEUS 22- COCHLEAR, CORP. APPROVAL FOR 08/28/96 CHANNEL COCHLEAR IMPLEMENTING A NEW IMPLANT SYSTEM ENGLEWOOD, CO DIAGNOSTIC AND 80112 PROGRAMMING SYSTEM SOFTWARE (DPS VERSION 6.125) P850035/S020 EBI SPF ELECTRO-BIOLOGY, THE DEVICE IS 08/20/96 IMPLANTABLE INC. INDICATED FOR USE AS SPINAL FUSION PARSIPPANY, NJ A SPINAL FUSION STIMULATOR MODEL 07054-1079 ADJUNCT TO INCREASE SPF-XL II THE PROBABILITY OF FUSION SUCCESS IN 3 OR MORE LEVELS P850079/S028 HYDRASOFT, COOPERVISION, INC. APPROVAL FOR 08/01/96 HYDRASOFT TORIC, REFORMATTING THE HYDRASOFT XW AND IRVINE, CA PACKAGE INSERT, HYDRASOFT TORIC 92718 PROFESSIONAL FITTING XW (METHALICON B) AND INFORMATION SOFT GUIDE, AND PATIENT (HYDROPHILIC) INSTRUCTIONS CONTACT LENSES P850089/S034 MEDTRONIC MEDTRONIC, INC. ALTERNATIVE PACKAGING 08/12/96 PACING LEADS DESIGN MINNEAPOLIS, MN 55432-3576 P860007/S018 INTERTACH II INTERMEDICS, INC. APPROVAL FOR THE USE 08/19/96 MODELS 262-16 OF AN ALTERNATE ANGLETON, TX CONDUCTIVE EPOXY AND 77515 A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS P860019/S112 SCIMED RANGER SCIMED LIFE SYSTEMS, THE DEVICE IS 08/29/96 PERCUTANEOUS INC. INDICATED FOR THE TRANSLUMINAL MAPLE GROVE, MN BALLOON DILATATION ANGIOPLASTY 55311-1566 OF THE STENOTIC (PTCA) CATHETER PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION P860019/S114 SCIMED NC BANDIT SCIMED LIFE SYSTEMS, MODIFICATION TO THE 08/27/96 PERCUTANEOUS INC. WRAP-IT ACCESSORY TRANSLUMINAL MAPLE GROVE, MN TOOL CORONARY 55311-1566 ANGIOPLASTY (PTCA) CATHETER P870015/S022 MEDSTONE STS MEDSTONE INTL., INC. HARDWARE AND 08/19/96 LITHOTRIPTER SOFTWARE CHANGES ALISO VIEJO, CA TO THE DEVICE 92656-4114 P870036/S039 MEDTRONIC MEDTRONICS NEW BALLOON SIZES 08/30/96 FALCON CORONARY INTERVENTIONAL TO BE ADDED TO THE BALLOON SAN DIEGO, CA FALCON 20 CORONARY DILATATION 92121-2256 BALLOON DILATATION CATHETERS CATHETER LINE AND THE ADDITION OF THE FALCON 30 AND FALCON 40 CORONARY BALLOON DILATATION CATHETER LINES ADDITIONALLY, SPECIFICATION AND QUALITY CONTROL INSPECTION CHANGES WERE REQUESTED P880040/S003 CELLFREE T CELL DIAGNOSTICS, CHANGE IN ADDRESS OF 08/07/96 INTERLEUKIN-2 INC. THE MANUFACTURING RECEPTOR BEAD WOBURN, MA SITE AND UPDATES AND ASSAY KIT 01801 REVISIONS IN STANDARD OPERATING PROCEDURES AND MANUFACTURING INFORMATION P890003/S045 MEDTRONIC VDD MEDTRONIC, INC. ALTERNATIVE PACKAGING 08/12/96 STEROID-ELUTING DESIGN LEAD MINNEAPOLIS, MN 55432-3576 P890023/S004 OCUFILCON D OCULAR SCIENCES/ 1)ADDITION OF AN IN- 08/28/96 SPHERICAL AND AMERICAN HYDRON MONOMER TINT TORIC EXTENDED CUPERTINO, CA INCORPORATING VAT WEAR CONTACT 95014 BLUE 6 DYE DURING THE LENSES POLYMERIZATION PHASE OF THE MANUFACTURING PROCESS; 2) USE OF BLISTER PACKAGING AS ALTERNATE PACKAGING MATERIAL; AND 3) ALTERNATE MANUFACTURING SITE P890027/S035 NUCLEUS 22- COCHLEAR, CORP. APPROVAL FOR 08/28/96 CHANNEL COCHLEAR IMPLEMENTING A NEW IMPLANT ENGLEWOOD, CO DIAGNOSTIC AND 80112 PROGRAMMING SYSTEM SOFTWARE (DPS VERSION 6.125) P890064/S004 HYBRID DIGENE DIAGNOSTICS, CHANGES IN 08/28/96 CAPTURE HPV INC. MANUFACTURING DNA ASSAY SILVER SPRING, MD METHODS, PROCEDURES, 20904 AND LABELING MODIFICATIONS P900023/S019 ABIOMED BVS ABIOMED, INC. ELIMINATION OF THE 08/19/96 5000 ISOLATOR VALVE BI-VENTRICULAR DANVERS, MA ASSEMBLY FROM THE BVS SUPPORT SYSTEM 01923 CONSOLE P900060/S011 CARBOMEDICS CARBOMEDICS, INC. APPROVAL FOR THE 21MM 08/12/96 PROSTHETIC HEART MITRAL CPHV, MODEL VALVE (CPHV) AUSTIN, TX M700 78752-1793 P900060/S013 CARBOMEDICS CARBOMEDICS, INC. APPROVAL FOR THE 08/27/96 PROSTHETIC HEART USE OF AN ALTERNATE VALVE (CPHV) AUSTIN, TX CONTROLLED MODELS A500, 78752-1793 ENVIRONMENT FOR R500, S500, M700, CPHV MANUFACTURING MAND S700 OPERATIONS P900061/S028 MODEL MEDTRONIC, INC. APPROVAL FOR NEW 08/06/96 7221/B/CX/D/E MODEL AND THE MODEL MICRO JEWEL MINNEAPOLIS, MN 6836Y CONNECTOR WITH ENDOTAK 55432-3576 SERIES LEADS INCLUDING 60, 70 AND 110 SERIES LEADS (MODELS 0060, 0062, 0063, 0064, 0070, 0072, 0073, 0074, 0075, 0113, 0115) AND THE MODEL 6836 Y CONNECTOR P910020/S015 RELAY/DASH/STRIDE/ INTERMEDICS, INC. APPROVAL FOR THE USE 08/19/96 DART PACING OF AN ALTERNATE SYSTEMS ANGLETON, TX CONDUCTIVE EPOXY AND 77515 A PRODUCTION PROCESS CHANGE FOR AUTOMATED APPLICATION OF THIS EPOXY IN THE MANUFACTURE OF IMPLANTABLE PULSE GENERATORS P910031/S009 FACT BALLOON CARDIOVASCULAR APPROVAL FOR THE 08/20/96 CORONARY DYNAMICS, INC. 22 MM MODELS OF THE DILATATION IRVINE, CA FACT AND ARC BALLOON CATHETER AND 92718 CORONARY DILATATION ARC BALLOON CATHETERS CORONARY DILATATION CATHETER P920004/S001 VASOSEAL DATASCOPE, CORP. ADDITION OF A REDUCED 08/01/96 VASCULAR TIME TO AMBULATION HEMOSTASIS MONTVALE, NJ CLAIM TO THE DEVICE 07645 INDICATIONS FOR USE P920004/S002 VASOSEAL COLLAGEN PRODUCTS CHANGES TO THE 08/01/96 VASCULAR DIVISION INSTRUCTIONS FOR USE HEMOSTASIS DEVICE MONTVALE, NJ TO ENHANCE THE 07645 SAFETY OF THE USE OF THE DEVICE P920015/S010 MEDTRONIC SPRINT MEDTRONIC, INC. APPROVAL FOR THE 08/06/96 MODEL 6932 MEDTRONIC SPRINT LEAD MINNEAPOLIS, MN MODEL 6932 LEAD 55432-3576 P930039/S001 MEDTRONIC MEDTRONIC, INC. ALTERNATIVE PACKAGING 08/12/96 SCREW-IN STEROID DESIGN ELUTING LEAD MINNEAPOLIS, MN 55432 P940008/S002 RES-Q INTERMEDICS, INC. APPROVAL FOR A 08/20/96 ARRHYTHMIA SUPPLEMENT WHICH CONTROL DEVICE ANGLETON, TX SATISFIES THE SYSTEMS 77515 REQUIREMENT TO SUBMIT A POST-APPROVAL STUDY PROTOCOL FOR THE INTERMEDICS EPICARDIAL PATCH DEFIBRILLATION LEADS P940008/S003 RES-Q INTERMEDICS, INC. APPROVAL TO CONSIDER 08/22/96 ARRHYTHMIA THE INFORMATION CONTROL DEVICE ANGLETON, TX PROVIDED IN THIS SYSTEMS 77515 SUPPLEMENT AS AN ALTERNATIVE RESPONSE TO THE CONDITIONS OF APPROVAL SET FORTH IN THE FDA LETTER DATED NOVEMBER 7, 1995, WHICH REQUIRED THAT REMAINING MINOR SOFTWARE ANOMALIES BE CORRECTED P940010/S001 OPTIGUIDE QLT PHOTOTHERAPEUTICS, CHANGE IN LABELING 08/07/96 FIBER OPTIC INC. CONSISTING OF ADDING DIFFUSER VANCOUVER, B.C., AN ADDITIONAL WARNING DCYL SERIES STATEMENT CONCERNING POSSIBLE LEAKAGE OF BLOOD INTO DIFFUSER CAP P940022/S001 CLARION ADVANCED BIONICS, MODIFY THE DESIGN OF 08/02/96 MULTI-STRATEGY CORP. THE CLARION MULTI- COCHLEAR IMPLANT SYLMAR, CA STRATEGY COCHLEAR VERSION 1.2 FOR 91342 IMPLANT FROM THE ADULTS ORIGINAL 1.0 VERSION TO THE MINIATURIZED 1.2 VERSION P940034/S003 GEN-PROBE GEN-PROBE, INC. APPROVAL FOR CHANGING 08/22/96 AMPLIFIED THE PACKAGE INSERT MYCOBACTERIUM SAN DIEGO, CA FOR THE MTD KIT TO TUBERCULOSIS 92121 INCLUDE AN ADDITIONAL DIRECT TEST (MTD WARNING AND AN TEST) EXPANDED LIMITATION REGARDING LOW POSITIVE RESULTS WITH MOTT P950039/S001 THINPREP CYTYC, CORP. RELOCATION OF CYTYC, 08/22/96 PROCESSOR CORP., FROM (MODEL TP 2000) BOXBOROUGH, MA MARLBOROUGH, MA TO 01719 BOXBOROUGH, MA
Updated 3/12/1997
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