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PMA Final Decisions Rendered for June 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.
P910074 CONTACLAIR EUREXPAN INDICATED FOR 06/20/96 MULTI-PURPOSE LABORATORIES CLEANING, RINSING, SOLUTION CELLETTES, FR DISINFECTING AND STORING DAILY AND EXTENDED WEAR CLEAR AND TINTED SOFT CONTACT LENSES PMA SUPPLEMENTAL APPROVALS P820018/S069 NETWORK TELECTRONICS PACING APPROVAL FOR THE 06/25/96 PROGRAMMER MODEL SYSTEMS NETWORK PROGRAMMER 9602 ENGLEWOOD, CO MODEL 9602 WITH 80112 APPLICATION SOFTWARE VERSION R5.3 P830071/S006 ALCON WETTING, ALCON LABORATORIES, ALTERNATE FORMULATION 06/04/96 SOAKING, INC. DEVICE INDICATED FOR CONDITIONING, AND FORT WORTH, TX THE DISINFECTION AND DISINFECTING 76134-2099 CONDITIONING AFTER SOLUTION ID 84392 CLEANING AND RINSING OF CLEAR AND TINTED DAILY AND EXTENDED WEAR P840024/S063 NUCLEUS 22 COCHLEAR REVISIONS TO THE 06/20/96 CHANNEL COCHLEAR CORPORATION WARNINGS SECTION IN IMPLANT ENGLEWOOD, CO THE PACKAGE INSERT 80112 AND PATIENT IDENTIFICATION CARD P840024/S064 NUCLEUS 22 COCHLEAR REDESIGN OF THE MINI 06/13/96 CHANNEL COCHLEAR CORPORATION COCHLEAR IMPLANT'S IMPLANT ENGLEWOOD, CO INTEGRATED CIRCUIT(IC) 80112 (IC2401) THE NEW IC IS DESIGNED TO OPTIMIZE ELECTROSTATIC DISCHARGE PROTECTION OF THE MINI COCHLEAR IMPLANT, MODEL C122M P840039/S049 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE 06/05/96 POSTERIOR CHAMBER INC. POWER RANGE FOR THE INTRAOCULAR CLEARWATER, FL ONE-PIECE POSTERIOR LENSES (IOLS) 34619 CHAMBER IOLS FROM (+4.0 D) - (+34 D) TO (-18.0 D) - (+45 D)
P840064/S017 VISCOAT ALCON LABORATORIES, 1) ALTERNATE 06/21/96 VISCOELASTIC INC. STERILIZATION PROCESS; SOLUTION FORT WORTH, TX USING 100% ETHYLENE 76134-2099 OXIDE 2) SHELF LIFE OF 24 MONTHS FOR VISCOAT AND 36 MONTHS FOR PROVISC; AND 3) ALTERNATE PACKAGING FOR PROVISC P840068/S019 VISTA DDD MODEL CPI/GUIDANT TWO NEW MODELS OF 06/19/96 942, 944, AND CORPORATION VISTA DDD PULSE SOFTWARE MODULE ST. PAUL, MN GENERATORS AND A MODEL 2052 55112-5798 SOFTWARE MODULE P860002/S017 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE 06/05/96 POSTERIOR CHAMBER INC. POWER RANGE FOR THE INTRAOCULAR CLEARWATER, FL ONE-PIECE POSTERIOR LENSES (IOLS) 34619 CHAMBER IOLS FROM (+4.0 D) - (+34 D) TO (-18.0 D) - (+45 D) P860019/S108 SCIMED WAVE SCIMED LIFE SYSTEMS, INTENDED FOR THE 06/10/96 PERCUTANEOUS INC. BALLOON DILATATION TRANSLUMINAL MAPLE GROVE, MN OF THE STENOTIC CORONARY 55311-1566 PORTION OF A CORONARY ANGIOPLASTY ARTERY OR BYPASS GRAFT (PTCA) STENOSIS FOR THE PERFUSION CATHETER PURPOSE OF IMPROVING MYOCARDIAL PERFUSION P870018/S014 LITHOSTAR SIEMENS MEDICAL 1)MODIFICATIONS TO A 06/06/96 SHOCK WAVE SYSTEMS, INC. PROGRAMMABLE READ SYSTEM C ISELIN, NJ ONLY MEMORY INTEGRATED 08830 CIRCUIT; AND 2)MINOR LABELING CHANGES P870018/S015 MOBILE SIEMENS MEDICAL APPROVAL FOR A MOBILE 06/05/96 LITHOSTAR SYSTEM, INC. VERSION OF THE WITH SHOCK ISELIN, NJ LITHOSTAR SHOCK WAVE WAVE SYSTEM C 08830 SYSTEM C (SWSC) P870018/S016 LITHOSTAR SIEMENS MEDICAL MODIFICATION OF 06/21/96 LITHOTRIPTER SYSTEMS, INC. USER'S MANUAL ISELIN, NJ 08830 P870076/S004 FALOPE-RING CIRCON-CABOT MEDICAL ALTERNATE 06/14/96 BAND CORPORATION MANUFACTURING SITE CONTRACEPTIVE LANGHORNE, PA TUBAL OCCLUSION 19047 SYSTEM P880003/S054 CORDIS PERCUTANEOUS CORDIS CORPORATION ALTERNATE 06/13/96 TRANSLUMINAL STERILIZATION SITE CORONARY MIAMI, FL (ISOMEDIX) IN ANGIOPLASTY 33102-5700 NORTHBOROUGH, DILATATION MASSACHUSETTS CATHETERS P880003/S059 CORDIS PERCUTANEOUS CORDIS CORPORATION MODIFIED BALLOON 06/05/96 TRANSLUMINAL FOLDING MACHINE CORONARY MIAMI LAKES, FL ANGIOPLASTY 33014-5700 (PTCA) DILATATION CATHETERS P880027/S038 ASUKA AND ASUKA SCHNEIDER (USA), INC. INDICATED FOR BALLOON 06/12/96 LONGY OVER-THE- DILATATION OF THE WIRE PERCUTANEOUS PLYMOUTH, MN STENOTIC PORTION OF TRANSLUMINAL 55442 A CORONARY ARTERY OR CORONARY BYPASS GRAFT STENOSIS ANGIOPLASTY (PTCA) FOR THE PURPOSE OF CATHETERS IMPROVING MYOCARDIAL PERFUSION P880038/S031 NETWORK TELECTRONICS PACING APPROVAL FOR THE 06/25/96 PROGRAMMER MODEL SYSTEMS NETWORK PROGRAMMER 9602 ENGLEWOOD, CO MODEL 9602 WITH 80112 APPLICATION SOFTWARE VERSION R5.3 P880090/S017 ONE-PIECE STORZ OPHTHALMICS, EXTENSION OF THE 06/05/96 ANTERIOR CHAMBER INC. POWER RANGE FOR THE INTRAOCULAR CLEARWATER, FL ONE-PIECE ANTERIOR LENSES (IOLS) 34619 CHAMBER IOLS FROM (+4.0 D) - (+34D) TO (-4.5 D) - (+45D) P890001/S011 LEOCOR PERCUTANEOUS LEOCOR, INC. CHANGE IN THE 06/13/96 ANGIOPLASTY INSTRUCTIONS FOR USE, CATHETER (PTCA), HOUSTON, TX ADDITION OF A PUMP MODEL 5S, LEOCOR 77058-2536 HEAD WITH LONGER CORFLO MODEL 7.5PT TUBING, CHANGE IN THE COATED PTCA, AND CLEANING PROCESS, AND CORFLO ADDITION OF STOPCOCKS HEMOPERFUSION PUMP ON THE PUMPS P890001/S014 LEOCOR PERCUTANEOUS LEOCOR, INC. REVISED LABELING 06/13/96 TRANSLUMINAL CORONARY HOUSTON, TX ANGIOPLASTY 77058-2536 CATHETER AND LEOCOR PTCA CATHETER MODEL PICO-ST (COATED) P890001/S015 LEOCOR PICO LEOCOR, INC. EXTENSION OF THE 06/07/96 RUNNER PTCA LEOCOR PICO RUNNER CATHETER HOUSTON, TX PTCA CATHETER LINE TO 77058-2536 INCLUDE A 4.0MM BALLOON DIAMETER P890027/S032 NUCLEUS 22 COCHLEAR REVISIONS TO THE 06/13/96 CHANNEL COCHLEAR CORPORATION WARNING SECTION IN IMPLANT ENGLEWOOD, CO THE PACKAGE INSERT 80112 AND PATIENT IDENTIFICATION CARD P890027/S033 NUCLEUS 22 COCHLEAR REDESIGN OF THE MINI 06/13/96 CHANNEL COCHLEAR CORPORATION COCHLEAR IMPLANT'S IMPLANT ENGLEWOOD, CO INTEGRATED CIRCUIT 80112 (IC2401) P890047/S010 PROVISC ALCON LABORATORIES, 1) ALTERNATE 06/21/96 VISCOELASTIC INC. STERILIZATION PROCESS MATERIAL FORT WORTH, TX USING 100% ETHYLENE 76134-2099 OXIDE 2) SHELF LIFE OF 24 MONTHS FOR VISCOAT AND 36 MONTHS FOR PROVISC 3) ALTERNATE PACKAGING FOR PROVISC P890055/S001 M3000 CONSTANT ARROW ADDITION OF THE 06/27/96 FLOW IMPLANTABLE INTERNATIONAL "MODEL 3000 PUMP WITH BOLUS WALPOLE, MA MEDICATION SAFETY VALVE 02081 CALCULATOR" TO THE LABELING P900047/S005 CLARIS ALLERGAN OPTICAL 1) DUPLICATE WET-N- 06/20/96 REWETTING DROPS SOAK REWETTING DROPS IRVINE, CA UNDER THE TRADE NAME 91713-9534 CLARIS REWETTING DROPS 2) ADDITIONAL STATEMENT TO THE DIRECTIONS SECTION P900070/S006 META DDDR TELECTRONICS PACING APPROVAL FOR THE 06/28/96 PACEMAKER PULSE SYSTEMS, INC. META DDDR PACEMAKER GENERATORS MODELS ENGLEWOOD, CO PULSE GENERATORS 1256, 1256D, & 80112 MODELS 1256, 1256D, 1256B (FORMERLY AND 1256B (FORMERLY 1256R) 1256R) P900070/S011 META DDDR PACING TELECTRONICS PACING MODIFICATION IN THE 06/21/96 SYSTEM SYSTEMS, INC. PULSE GENERATOR ENGLEWOOD, CO DESIGN IN THE 80112 TELEMETRY COIL CONNECTION P900070/S012 NETWORK TELECTRONICS PACING APPROVAL FOR THE 06/25/96 PROGRAMMER MODEL SYSTEMS, INC. NETWORK PROGRAMMER 9602 ENGLEWOOD, CO MODEL 9602 WITH 80112 APPLICATION SOFTWARE VERSION R5.3. P910023/S014 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR THE 06/11/96 THERAPY VENTRITEX EXTERNAL DEFIBRILLATOR SUNNYVALE, CA STIMULATOR ADAPTER SYSTEM 94086-6527 (VESA) AND THE VENTRITEX HIGH VOLTAGE Y-ADAPTER P910023/S018 CADET TIERED VENTRITEX, INC. APPROVAL FOR TWO 06/11/96 THERAPY HEADER CONFIGURATIONS DEFIBRILLATOR SUNNYVALE, CA (MODELS V-105/V115 SYSTEM 94086-6527 AND MODELS V-105B/V-115B, AS PART OF THE CADET TIERED THERAPY DEFIBRILLATOR SYSTEM P920051/S003 STORZ MODULITH KARL STORZ NEW MODEL 06/21/96 LITHOTRIPTER, LITHOTRIPSY-AMERICA THE DEVICE, AS MODEL SLX KENNESAW, GA MODIFIED, WILL BE 30144 MARKETED UNDER THE TRADE NAME THE STORZ MODULITH LITHOTRIPTER MODEL SLX P930029/S005 ADDITION OF RF MEDTRONIC ADDITION OF THE RF 06/11/96 PERFORMR CARDIOPULMONARY DIV. PERFORMR SERIES OF SAN JOSE, CA CARDIAC ABLATION 95134-1806 CATHETERS FOR THE ATAKR RFCA SYSTEM P940034/S002 GEN-PROBE GEN-PROBE INC. MODIFIED PACKAGE 06/05/96 AMPLIFIED INSERT TO INCLUDE MYCOBACTERIUM SAN DIEGO, CA MORE DETAILS ON TUBERCULOSIS 92121-1589 ADEQUATE VORTEXING DIRECT (MTD) TEST P950014/S001 PROSTATRON EDAP TECHNOMED APPROVAL TO SUPPLY 06/20/96 GROUP (USA), INC. THE PROSTATRON CAMBRIDGE, MA TREATMENT CATHETER 02139 (I.E., THE PROSTAPROBE) IN STERILE FORM
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