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PMA Final Decisions Rendered for March 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.
P890055 MODEL 3000 ARROW INDICATED FOR THE 03/11/96 CONSTANT FLOW INTERNATIONAL CONTINUOUS REGIONAL IMPLANTABLE PUMP WALPOLE, MA INTRA-ARTERIAL DELIVERY WITH BOLUS SAFETY 02081 OF 2'-DEOXY-5- VALVE FLUOROURIDINE (FUDER, HEPARINIZED SALINE, NORMAL SALINE, AND BACTERIOSTATIC WATER P900033 INTEGRA INTEGRA LIFESCIENCES INDICATED FOR THE POST- 03/01/96 (ARTIFICIAL SKIN) CORP. EXCISIONAL TREATMENT OF PLAINSBORO, NJ LIFE-THREATENING FULL- 08536 THICKNESS OR DEEP PARTIAL-THICKNESS THERMAL INJURY WHERE SUFFICIENT AUTOGRAFT IS NOT AVAILABLE P930016 VISX EXCIMER VISX, INC. INDICATED FOR A 6.0 MM 03/27/96 LASER SYSTEM ABLATION ZONE, MYOPIC MODELS "B" AND SANTA CLARA, CA PHOTOREFRACTIVE "C" 95051 KERATECTOMY (PRK) IN PATIENTS WHO MEET SPECIFIC CRITERIA P930039 CAPSUREFIX PACING MEDTRONIC, INC. INDICATED TO BE USED WITH 03/29/96 LEAD, MODEL 4068 A PULSE GENERATOR AS PART MINNEAPOLIS, MN OF A CARDIAC PACING SYSTEM 55432-3576 P940022 CLARION ADVANCED BIONICS INDICATED TO RESTORE A 03/22/96 MULTI-STRATEGY CORP. LEVEL OF AUDITORY COCHLEAR IMPLANT SYLMAR, CA SENSATION TO INDIVIDUALS 91342 WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE P950011 TRUQUANT BIOMIRA AN IN VITRO DIAGNOSTIC 03/29/96 BR RIA DIAGNOSTICS, INC. DEVICE FOR THE ROCKVILLE, MD QUANTITATIVE DETERMINATION 20855 OF CA 27.29 ANTIGEN IN SERUM OR EDTA PLASMA OF PATIENTS PREVIOUSLY TREATED FOR STAGE II OR III BREAST CANCER
N18033/S028 MOLDED VISTAKON, JOHNSON UTILIZATION OF AN 03/05/96 ETAFILCON A AND JOHNSON, INC. ALTERNATE PROTOCOL SOFT (HYDROPHILIC) JACKSONVILLE, FL FOR ESTABLISHING CONTACT LENSES 32247 SHELF-LIFE STABILITY (CLEAR AND WITH VISIBILITY TINT) P810002/S038 ST. JUDE MEDICAL ST. JUDE MEDICAL, EXTENSION OF THE SHELF 03/13/96 MECHANICAL HEART INC. LIFE OF THE MECHANICAL VALVE ST. PAUL, MN HEART VALVE (ALL 55117 CURRENTLY APPROVED MODELS) AND THE COATED AORTIC VALVED GRAFT (CAVG), MODEL CAVG-404 P810002/S039 ST. JUDE MEDICAL ST. JUDE MEDICAL, EXPANDED VERSION OF 03/21/96 MECHANICAL HEART INC. THE DEVICE WITH VALVE ST. PAUL, MN TEFLON SEWING CUFF (EXPANDED SEWING 55117 CUFF) P820003/S071 VERSATRAX PULSE MEDTRONIC, INC. ALTERNATE 03/13/96 GENERATOR SYSTEM STERILIZATION ENHANCEMENT MINNEAPOLIS, MN PROCESS MODULE 55432-3576 P820021/S028 FOCUS AND NEWVUES CIBA VISION, AUTOMATED 03/18/96 (VILFILCON A) CORP. MANUFACTURING LINE SOFT (HYDROPHILIC) DULUTH, GA AND PROCESS CONTACT LENSES 30136-1518 P820049/S063 POSTERIOR CHAMBER ALLERGAN MEDICAL ADDITION OF THE 03/11/96 PMMA INTRAOCULAR OPTICS STERILIZATION LENSES (IOLS) IRVINE, CA SERVICES OF TENNESSEE 92713-9534 (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE FOR IOLS P830026/S066 COSMOS II INTERMEDICS, INC. INTRODUCTION OF 03/22/96 PACING SYSTEM LABELING ADDRESSING ANGLETON, TX COMPATIBILITY OF 77515 PACEMAKERS WITH CELLULAR TELEPHONES P840019/S012 TANDEM-R CEA HYBRITECH, INC. ENHANCEMENTS IN THE 03/07/96 IMMUNORADIOMETRIC FORMULATION OF THE ASSAY SAN DIEGO, CA ALKALINE PHOSPHATASE- 92196 LABELED ANTI-CEA CONJUGATE AND THE ADDITION OF THE BLOCKING REAGENT POLY MAK 33 NEW TRADE NAME:TANDEM-E CEA P840024/S060 NUCLEUS 22 COCHLEAR, CORP. COMPONENT REVISIONS, 03/26/96 CHANNEL COCHLEAR LABELING, AND IMPLANT SYSTEM ENGLEWOOD, CO MANUFACTURING CHANGES 80112 P840064/S015 VISCOAT ALCON LABORATORIES ALTERNATE MANUFACTURING 03/22/96 VISCOELASTIC SITE; 100% ETHYLENE OXIDE MATERIAL FORT WORTH, TX STERILIZATION PROCESS; 76134-2099 AND INCREASE IN THE ALLOWABLE FILL VOLUME TO 0.75 ML P840064/S016 DUOVISC ALCON LABORATORIES ALTERNATE MANUFACTURING 03/26/96 VISCOELASTIC SITE (PUURS, BELGIUM) SYSTEM FORT WORTH, TX AND A SINGLE BLISTER 76134-2099 PACKAGE CONTAINING BOTH PROVISC AND VISCOAT WITH DELIVERY CANNULAS (24 MONTHS EXP.) P840068/S027 VIGOR DDD MODEL CARDIAC ADDITION OF AN ALTERNATE 03/12/96 950 PACEMAKER PACEMAKERS (CPI) LOWER PROFILE CONNECTOR ST. PAUL, MN TOP 55112-5798 P840068/S028 VIGOR MODEL 2880 GUIDANT CORP. DEVICE USED IN 03/22/96 SOFTWARE CONJUNCTION WITH THE APPLICATION ST. PAUL, MN MODEL 2909 MULTIPLE 55112-5798 APPLICATION UTILITY (MAU) ON MODEL 2950 PRM FOR PROGRAMMING OF ALL COMMERCIALLY AVAILABLE VIGOR PACEMAKERS P850051/S052 ACTIVITRAX PULSE MEDTRONIC, INC. ALTERNATE STERILIZATION 03/13/96 GENERATOR SYSTEM PROCESS PACEMAKERS MINNEAPOLIS, MN 55432 P860007/S017 INTERTACH INTERMEDICS, INC. INTRODUCTION OF 03/22/96 PACING SYSTEM LABELING ADDRESSING ANGLETON, TX COMPATIBILITY OF 77515 PACEMAKERS WITH CELLULAR TELEPHONES P860034/S014 ANTERIOR CHAMBER ALLERGAN MEDICAL ADDITION OF 03/11/96 PMMA IOLS OPTICS STERILIZATION IRVINE, CA SERVICES OF TENNESSEE 92713-9534 (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE P870018/S011 LITHOSTAR SHOCK SIEMENS MEDICAL MODIFICATIONS MADE TO 03/01/96 WAVE SYSTEM C SYSTEMS, INC. THE SHOCK TUBE, WATER ISELIN, NJ CONDITIONING SYSTEM, 08830 SHOCK WAVE GENERATOR, SHOCK WAVE ENERGY SETTING, AND LABELING P870018/S013 LITHOSTAR SIEMENS MEDICAL MODIFICATIONS MADE TO 03/13/96 LITHOTRIPTER SYSTEMS, INC. THE ZOOM FUNCTION AND ISELIN, NJ LABELING; NEW TRADE 08830 NAME:LITHOSTAR P870049/S024 MICROSCAN RAPID DADE OFLOXACIN TO BE ADDED 03/12/96 FLUOROGENIC INTERNATIONAL TO THE GRAM-NEGATIVE PANELS WEST SACRAMENTO, CA RAPID FLUOROGENIC 95691 PANELS AT THE EQUIVALENCY CONCENTRATIONS OF 0.25 TO 16 UG/ML P870076/S003 FALOPE-RING CABOT MEDICAL CHANGE STERILIZATION 03/01/96 BAND AND CORP. FACILITY TO THE APPLICATOR LANGHORNE, PA MEDICAL MANUFACTURING SYSTEM 19047 CORP. ERIE, PA P880003/S052 CORDIS PTCA CORDIS CORP. NEW MODELS:TITAN AND 03/13/96 DILATATION TITAN XL 3.25 AND CATHETER MIAMI, FL 3.75MM AND 9 OR 18MM 33102-5700 LENGTHS; MODIFIED LABELING AND BONDING PROCESS P880032/S002 BIO-RAD BIO-RAD CHANGE IN 03/01/96 CYCLOSPORINE BY LABORATORIES MANUFACTURER SITE FOR HPLC TEST HERCULES, CA THE ANALYTICAL 94547 CARTRIDGE AND A CHANGE IN VENDOR FOR THE "CLEAN UP" COLUMNS FOR THE CYCLOSPORIN TEST BY HPLC P880081/S020 ULTRAVIOLET- ALLERGAN MEDICAL ADDITION OF 03/11/96 ABSORBING OPTICS STERILIZATION SILICONE IRVINE, CA SERVICES OF TENNESSEE POSTERIOR 92713-9534 (SST) AS AN ALTERNATE CHAMBER IOLS 100% ETO STERILIZATION SITE P890003/S039 MEDTRONIC MEDTRONIC, INC. NEW MODELS:THERA VDD 03/22/96 THERA VDD MODEL 8968: LEAD 9879E 8968I AND PRODIGY MINNEAPOLIS, MN SOFTWARE AND 9759 MODEL 8168 PULSE 55432-3576 MEMORYMOD MODELS GENERATORS, MODEL 5032 CAPSURE VDD LEAD, MODEL 9879E SOFTWARE, AND MODEL P890027/S029 NUCLEUS 22 COCHLEAR CORP COMPONENT REVISIONS, 03/26/96 CHANNEL COCHLEAR LABELING, AND IMPLANT ENGLEWOOD, CO MANUFACTURING CHANGES 80112 P890047/S008 PROVISC ALCON CHANGE IN MANUFACTURING 03/22/96 VISCOELASTIC LABORATORIES SITE AND METHOD; DESIGN MATERIAL FORT WORTH, TX CHANGE 76134-2099 P890047/S009 DUOVISC ALCON LABORATORIES MANUFACTURE OF DEVICE 03/26/96 VISCOELASTIC AT ALCON-COUVREUR SYSTEM FORT WORTH, TX (PUURS, BELGIUM) AND 76134-2099 A SINGLE BLISTER PACKAGE WILL CONTAIN BOTH PROVISC AND VISCOAT WITH DELIVERY CANNULAS (24 MONTHS EXP.) P890056/S004 POSTERIOR CHAMBER ALLERGAN MEDICAL ADDITION OF 03/11/96 PMMA IOLS OPTICS STERILIZATION IRVINE, CA SERVICES OF TENNESSEE 92713-9534 (SST) AS AN ALTERNATE 100% ETO STERILIZATION SITE P900023/S016 ABIOMED BVS ABIOMED, INC. CHANGE TO A COMPONENT 03/12/96 5000 IN THE BVS 5000 BI-VENTRICULAR DANVERS, MA CONSOLE, THE HONEYWELL SUPPORT SYSTEM 01923 SOLENOID VALVE, AND EXTENSION OF THE RECOMMENDED REPLACEMENT TIME P900030/S005 CONTIGEN BARD COLLAGEN CORP. MODIFIED PACKAGING 03/08/96 COLLAGEN IMPLANT CONFIGURATION; LOCATION PALO ALTO, CA CHANGE OF THE SKIN TEST 94303-3308 PACKAGING OPERATION; REVISION OF WARNING STATEMENT; AND UPDATING PATIENT RECORD AND SKIN TEST CARD LABELING P900059/S002 ALBUNEX MOLECULAR BIOSYSTEMS, RELEASE OF THE FINAL 03/01/96 ULTRASOUND INC. PRODUCT BASED ON USP CONTRAST SAN DIEGO, CA STERILITY TESTING MICROSPHERES 92121-2789 PERFORMED BY MOLECULAR BIOSYSTEM'S, INC. P910020/S010 RATE ADAPTIVE PULSE INTERMEDICS, INC. ALTERNATE 03/15/96 GENERATORS ANGLETON, TX ACCELEROMETER 77515 P910020/S011 RELAY FAMILY OF INTERMEDICS, INC. CHANGE IN STERILANT 03/22/96 PULSE GENERATORS, FROM A MIXTURE OF 12% INCLUDING THE ANGLETON, TX ETHYLENE OXIDE AND RELAY, DASH, 77515 88% FREON TO A MIXTURE STRIDE, DART, OF 8.5% ETHYLENE OXIDE AND UNITY C AND 91.5% CARBON DIOXIDE P910020/S014 RELAY/DASH/STRIDE INTERMEDICS, INC. INTRODUCTION OF 03/22/96 STRIDE/DART LABELING ADDRESSING PACING SYSTEMS ANGLETON, TX COMPATIBILITY OF 77515 PACEMAKERS WITH CELLULAR TELEPHONES P910031/S005 CATHSCANNER ORACLE ENDOSONICS CORP. NEW MODEL: ARC 03/13/96 MICRO PTCA CORONARY BALLOON CATHETER/ARC RANCHO CORDOVA, CA DILATATION CATHETER CORONARY BALLOON 95670 DILATATION CATHETER P910077/S009 VENTAK PRX III CPI/GUIDANT SUBPECTORAL 03/14/96 AICD PULSE CORP. IMPLANTATION OF THE GENERATOR ST. PAUL, MN VENTAK PRX III PULSE 55112-5798 GENERATOR P920014/S004 TCI HEARTMATE THERMO CARDIOSYSTEMS, REVISED LABELING TO 03/13/96 IP LVAS INC. DELETE THE HEMODYNAMIC WOBURN, MA CRITERIA FROM THE 01888-2697 INDICATIONS FOR USE P920015/S005 MEDTRONIC MODEL MEDTRONIC, INC. ADDITION OF MODEL 03/22/96 6937 TRANSVENE 6937 TRANSVENE SUPERIOR VENA MINNEAPOLIS, MN SUPERIOR VENA CAVA CAVA LEAD 55432-3576 LEAD P920015/S007 MEDTRONIC MEDTRONIC, INC. ADDITION OF MODEL 03/13/96 MODEL 6934S 6934S TRANSVENE-RIGHT TRANSVENE-RIGHT MINNEAPOLIS, MN VENTRICULAR LEAD VENTRICULAR LEAD 55432-3576 P930014/S002 ACRYSOF MODELS ALCON LABORATORIES ALTERNATE 03/26/96 MA60BM AND MA30BA STERILIZATION PROCESS ULTRAVIOLET- FORT WORTH, TX INCLUDING AERATION ABSORBING ACRYLIC 76134 AND THE ESTABLISHMENT FOLDABLE OF THE BIOLOGICAL INTRAOCULAR LENSES INDICATOR INCUBATION (IOLS) TIME AT THE HUNTINGTON, WEST VIRGINIA SITE P940008/S001 RES-Q ACD INTERMEDICS, INC. ALTERNATE STERILIZATION 03/21/96 MODEL 101-1 PROCESS AND MODEL 101-01R ANGLETON, TX 77515 P940031/S003 VIGOR MODEL GUIDANT CORP. USE OF THE VIGOR 03/21/96 2880 SOFTWARE MODEL 2880 USED IN APPLICATION ST. PAUL, MN CONJUNCTION WITH THE 55112-5798 MODEL 2909 ON MODEL 2950 PRM FOR PROGRAMMING ALL COMMERCIALLY AVAILABLE VIGOR PACEMAKERS
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