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PMA Final Decisions Rendered for February 1996 |
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.
P910018 LIPOSORBER KANEKA AMERICA THE DEVICE IS A 02/21/96 LA-15 SYSTEM CORP. LOW DENSITY NEW YORK, NY LIPOPROTEIN (LDL) 10022 APHERESIS SYSTEM FOR CERTAIN HIGH RISK PATIENT POPULATIONS P950018 PERFLUORON INFINITECH, INC. THE DEVICE IS AN 02/29/96 (PURIFIED INTRAOPERATIVE TOOL PERFLUORO-N- CHESTERFIELD, MO FOR USE DURING OCTANE LIQUID) 63005 VITREORETINAL SURGERY IN PATIENTS WITH RETINAL DETACHMENTS
N12159/S015 SURGICEL JOHNSON & JOHNSON MANUFACTURING CHANGE 02/01/96 FIBRILLAR MEDICAL, INC. WHICH ADDS A STEP TO ABSORBABLE ARLINGTON, TX FORM A FIBRILLAR HEMOSTAT 76004-3130 STRUCTURE FOR THE DEVICE N17786/S025 ALLERGAN ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 HYDROCARE STERILIZATION SITE CLEANING AND IRVINE, CA AND THE USE OF 100% DISINFECTING 92713-9534 ETHYLENE OXIDE TO SOLUTION STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS N18020/S041 ALLERGAN ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 HYDROCARE STERILIZATION SITE PRESERVED SALINE IRVINE, CA AND THE USE OF 100% SOLUTION 92713-9534 ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS P790017/S049 BALLOON C.R. BARD, INC. MANUFACTURING CHANGES 02/26/96 DILATION TO THE BALLOON AND CATHETERS BILLERICA, MA INCLUDE THE USE OF A 01821 BALLOON PROTECTOR; NEW TRADE NAME PET ELITE P790024/S025 LC-65 DAILY ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 CLEANER STERILIZATION SITE IRVINE, CA AND THE USE OF 100% 92713-9534 ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS P790025/S007 ABBOTT HBE ABBOTT CHANGE IN 02/26/96 (RDNA) EIA LABORATORIES MANUFACTURING TEST KIT ABBOTT PARK, IL PROCESS FOR BEAD 60064-3500 COATING P800022/S048 ZYDERM I AND II COLLAGEN CORP. MANUFACTURING CHANGE 02/01/96 AND ZYPLAST COLLAGEN IMPLANTS PALO ALTO, CA 94303 P800065/S015 LENS-WET ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 LUBRICATING STERILIZATION SITE AND REWETTING IRVINE, CA AND THE USE OF 100% SOLUTION 92713-9534 ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS P810046/S158 ACS CONCORDE ADVANCED APPROVAL FOR ACS 02/05/96 CORONARY CARDIOVASCULAR CONCORDE CORONARY DILATATION SANTA CLARA, CA DILATATION CATHETER CATHETER 95052-8167 P810046/S159 ACS ENDURA ADVANCED APPROVAL FOR THE ACS 02/26/96 CORONARY CARDIOVASCULAR ENDURA CORONARY DILATATION SANTA CLARA, CA DILATATION CATHETER CATHETER 95052-8167 P840024/S055 NUCLEUS 22 COCHLEAR CORP. COMPONENT AND PROCESS 02/13/96 CHANNEL COCHLEAR CHANGES IMPLANT ENGLEWOOD, CO 80112 P840039/S030 SINGLE-PIECE STORZ OPHTHALMICS, ADDITION OF D & C 02/07/96 ULTRAVIOLET- INC. GREEN NO. 6 DYE TO ABSORBING CLEARWATER, FL THE HAPTICS; NEW POSTERIOR 34619 TRADE NAME BLUE CHAMBER VISTA INTRAOCULAR LENSES (IOLS) P840039/S031 ULTRAVIOLET- STORZ OPHTHALMICS, ADDITIONAL/ALTERNATIVE 02/07/96 ABSORBING INC. VENDOR FOR POSTERIOR CLEARWATER, FL POLYMETHYMETHACRYLATE CHAMBER 34619 (PMMA) WITH INTRAOCULAR ULTRAVIOLET- LENSES (IOLS) ABSORBER CYASORB 24 AND A NEW FORMULATION OF THE PMMA P840060/S022 POSTERIOR CHAMBER ALCON LABORATORIES, TIER A MODELS 02/20/96 INTRAOCULAR LENSES (IOLS) FORT WORTH, TX 76134-2099 P840066/S029 CONSEPT CLEANING ALLERGAN, INC. UNPRESERVED 02/29/96 AND DISINFECTING FORMULATION OF SYSTEM IRVINE, CA CONSEPT-2 92713 NEUTRALIZING AND RINSING SOLUTION TO BE PACKAGED IN A NON-AEROSOL CONTAINER P850088/S034 OXYSEPT 1/ ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 ULTRACARE STERILIZATION SITE DISINFECTING IRVINE, CA AND THE USE OF 100% SOLUTION 92713-9534 ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS P860019/S109 SCIMED SCIMED LIFE SYSTEMS, USE OF AN EPOXY 02/05/96 PERCUTANEOUS INC. ADHESIVE IN THE TRANSLUMINAL MAPLE GROVE, MN MANIFOLD OF THE BANDIT CORONARY 55311-1566 POC BANDIT, AND THE ANGIOPLASTY 15 MM NC BANDIT CATHETERS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETERS P860019/S110 SCIMED SCIMED LIFE SYSTEMS, APPROVAL FOR:1)10 AND 02/26/96 PERCUTANEOUS INC. 20 MM BALLOON TRANSLUMINAL MAPLE GROVE, MN LENGTHS; 2) 2.0 AND CORONARY 55311-1566 2.25 DIAMETER ANGIOPLASTY BALLOONS IN THE 20 MM CATHETERS LENGTH; AND 3) THE USE OF AN EPOXY ADHESIVE P870025/S004 MODEL 146 FETAL COROMETRICS MEDICAL CHANGES IN THE 02/01/96 ACOUSTIC SYSTEMS, INC. QUALITY CONTROL STIMULATOR WALLINGFORD, CT AND MANUFACTURING 06492-0333 PRACTICES FOR THE TRANSDUCER P870026/S007 RESOLVE/GP ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 DAILY CLEANER STERILIZATION SITE IRVINE, CA AND THE USE OF 100% 92713-9534 ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS P870037/S008 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 WETTING AND STERILIZATION SITE SOAKING IRVINE, CA AND THE USE OF 100% SOLUTION 92713-9534 ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS P880047/S004 INTERCEED JOHNSON & JOHNSON LABELING CHANGES 02/08/96 ABSORBABLE MEDICAL, INC. ADHESION BARRIER ARLINGTON, TX 76004-9962 P880072/S036 MODIFIED J-LOOP MEDICAL DEVELOPMENT ALTERNATE CONTRACT 02/12/96 POSTERIOR CHAMBER RESEARCH, INC. STERILIZER, MEDICAL INTRAOCULAR ST. PETERSBURG, FL MANUFACTURING, CORP., LENSES (IOLS) 33716 ERIE, PA 16510, AND CONVERSION FROM 12/88 ETHYLENE OXIDE (ETO/ FREON TO 100% ETO STERILIZATION P890027/S025 NUCLEUS 22 COCHLEAR CORP. COMPONENT AND PROCESS 02/13/96 CHANNEL COCHLEAR CHANGES IMPLANT ENGLEWOOD, CO 80112 P890061/S011 VENTAK P MODEL GUIDANT CORPORATION REPLACING THE CURRENT 02/20/96 1600 CONNECTOR TOP MATERIAL ST. PAUL, MN FOR THE ABOVE AICD 55112-5798 MODEL, PELLETHANE 2363- 75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE P900030/S004 CONTIGEN BARD COLLAGEN CORP. APPROVAL FOR A 02/01/96 COLLAGEN IMPLANT MANUFACTURING CHANGE PALO ALTO, CA 94303 P900039/S009 COLLAGRAFT BONE COLLAGEN CORP. APPROVAL FOR A 02/01/96 GRAFT MATRIX MANUFACTURING CHANGE PALO ALTO, CA 94303 P900047/S004 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 REWETTING DROPS STERILIZATION SITE SANTA ISABEL, PR AND USE OF 100% 00757 ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS P910075/S006 COMPLETE ALLERGAN OPTICAL ALTERNATE CONTRACT 02/23/96 BRAND MULTI- STERILIZATION SITE PURPOSE IRVINE, CA AND USE OF 100% SOLUTION 92713-9534 ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CAPS P910077/S010 VENTAK PRX GUIDANT CORP. REPLACING THE CURRENT 02/05/96 MODEL 1705, CONNECTOR TOP MATERIAL PRX II MODEL ST. PAUL, MN FOR THE ABOVE AICD 1715, AND PRX 55112-5798 MODEL, PELLETHANE 2363- III MODELS 1720/ 75D POLYURETHANE, WITH 1725 TECOTHANE TT1075D-M POLYURETHANE P910077/S011 VENTAK PRX II/ CPI/GUIDANT, APPROVAL FOR THE USE 02/05/96 III AICD CORP. OF MODEL 2872 SYSTEMS ST. PAUL, MN SOFTWARE APPLICATION, 551125798 REV. 4.1 AND MODEL 2909 MULTIPLE APPLICATION UTILITY (MAU) WITH THE VENTAK PRX II/III P920021/S001 OPUS CEA TEST BEHRING DIAGNOSTICS, APPROVAL TO ADD THE 02/23/96 SYSTEM INC. CEA TEST SYSTEM TO WESTWOOD, MA THE OPUS PLUS AND 02090 OPUS MAGNUM ANALYZERS. THE SAME TEST SYSTEM IS USED ON ALL THREE INSTRUMENTS P920047/S003 EP TECHNOLOGIES EP TECHNOLOGIES, INC. ADDITION OF 02/05/9 EPT-100 CARDIAC ALTERNATIVE CATHETER ABLATION SYSTEM SUNNYVALE, CA CONFIGURATIONS 94086 P930029/S006 ATAKR RFCA MEDTRONIC APPROVAL OF THE 02/22/96 SYSTEM CARDIORHYTHM ABLATION TRACKR SAN JOSE, CA SOFTWARE FOR USE WITH 95134-1806 THE ATAKR RF CATHETER ABLATION GENERATOR SYSTEM P930035/S004 VENTAK P2 MODEL GUIDANT CORPORATION REPLACING THE CURRENT 02/20/96 1625 AND P3 CONNECTOR TOP MATERIAL MODELS 1630/1635 ST. PAUL, MN FOR THE ABOVE AICD 55112-5798 MODEL, PELLETHANE 2363- 75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE P940031/S001 VIGOR(TM) DR CARDIAC PACEMAKERS, REPLACING THE CURRENT 02/20/96 PACEMAKER SYSTEM INC. CONNECTOR TOP MATERIAL ST PAUL, MN FOR THE ABOVE AICD 55112 MODEL, PELLETHANE 2363- 75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE P940031/S002 VIGOR DR CARDIAC ADDING AN ALTERNATE 02/26/96 MODEL 1230 PACEMAKERS (CPI) LOWER PROFILE CONNECTOR PACEMAKER ST. PAUL, MN TOP FOR THE VIGOR DR 55112-5798 MODEL 1230 PACEMAKERS
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