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PMA Final Decisions Rendered for July 1995 |
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.
P910003 WESLEY-JESSEN WESLEY-JESSEN INDICATED FOR USE 07/07/95 COE-405 IN THE CHEMICAL DISINFECTION DES PLAINES, IL DISINFECTION OF TABLET 60018 SOFT (HYDROPHILIC) CONTACT LENSES P940007 MODEL WS-100 PHARMACIA, INC. INDICATED FOR PRIMARY 07/20/95 PLIOLENS IMPLANTATION FOR ULTRAVIOLET- DUBLIN, OH VISUAL CORRECTION OF ABSORBING 43017 APHAKIA IN PERSONS SILICONE 60 YEARS OF AGE OR POSTERIOR OLDER CHAMBER INTRAOCULAR LENS (IOL)
N5798 /S007 OXYCEL OXIDIZED BECTON DICKINSON CHANGE IN THE QUALITY 07/24/95 CELLULOSE AND COMPANY CONTROL PROCEDURES FRANKLIN LAKES, NJ FOR 07417-1881 POST-STERILIZATION LOTS OF OXYCEL N17511 /S010 HYSKON MEDISAN REVISED LABELING 07/18/95 HYSTEROSCOPY PHARMACEUTICALS, INC. FLUID 32% (W/V) PARSIPPANY, NJ DEXTRAN IN 07054 DEXTROSE N17511 /S011 HYSKON MEDISAN USE OF A LAGARDE 07/18/95 HYSTEROSCOPY PHARMACEUTICALS, INC. STERILIZER TO FLUID 32% (W/V) PARSIPPANY, N.J. TERMINALLY STERILIZE DEXTRAN IN 07054 HYSKON HYSTEROSCOPY DEXTROSE FLUID, 32% (DEXTRAN 70) IN 100ML TO 250ML GLASS BOTTLE N17679 /S029 TETRAFILCON A COOPERVISION, INC. REDUCTION OF THE 07/28/95 HYDROPHILIC INCUBATION TIME OF CONTACT LENS FAIRPORT, N.Y. THE BIOLOGICAL 14450 INDICATOR USED IN THE LENS STERILIZATION PROCESS TO FORTY-EIGHT HOURS P800049/S006 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS P810001/S011 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS P810002/S035 ST. JUDE MEDICAL ST. JUDE MEDICAL, INC. ALTERNATE SUPPLIER OF 07/31/95 MECHANICAL HEART THE PYROLITIC CARBON VALVE ST. PAUL, MN LEAFLET & ORIFICE 55117 COMPONENTS USED IN THE ST. JUDE MEDICAL MECHANICAL HEART VALVE P810018/S034 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS P810032/S047 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS P820018/S061 AUTIMA/AURORA TELECRONICS, INC. ADDITION OF 07/12/95 CARDIAC PACING NON-INVASIVE SYSTEM - REFLEX ENGLEWOOD, CO PROGRAMMED STIMULATION DDD MODELS 8224 & 80112 (NIPS) 8223E, REFLEX MODELS 8218 & 8220E, & SIMPLEX MODEL 8232 PULSE GENERATORS P820035/S013 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS P820049/S061 MODEL PC-10 PMMA ALLERGAN MEDICAL SINGLE-POUCH TYVEK 07/28/95 POSTERIOR CHAMBER OPTICS PACKAGING OF LENSES, INTRAOCULAR LENS IRVINE, CA STERILIZATION OF (IOL) 92718 LENSES USING PREVIOUSLY APPROVED 100% ETO STERILIZATION CYCLES & A 5 YEAR SHELF LIFE P830040/S024 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS P830066/S012 ABBOTT CEA-RIA ABBOT LABORATORIES MODIFICATION OF THE 07/12/95 MONOCLONAL PACKAGE LABELING TO ABBOTT PARK, IL DECREASE THE "HOOK" 60064-3500 VALUE FROM 100,000 TO 60,000 NG CEA/ML P830079/S011 INSTAT* COLLAGEN JOHNSON & JOHNSON APPROVAL TO MARKET 07/07/95 ABSORBABLE MEDICAL, INC. INSTAT COLLAGEN HEMOSTAT ARLINGTON, TX ABSORBABLE HEMOSTAT 76004-3130 (ALL SIZES) FOR ENDOSCOPIC PROCEDURES P840001/S036 MEDTRONIC NEURO MEDTRONIC NEUROLOGICAL RELOCATION OF THE 07/13/95 MODELS:7491, STERILIZATION/PACKAGI 7492, 7493, 7494, MINNEAPOLIS, MN NG FACILITY & A 7495, & 7496 55440-9087 MODIFICATION IN THE EXTENSIONS STERILIZATION PROCESS P840024/S028 NUCLEUS 22 COCHLEAR CORPORATION NUCLEUS 22 07/28/95 CHANNEL COCHLEAR CHANNEL COCHLEAR IMPLANT FOR ENGLEWOOD, CO IMPLANT FOR PRELINGUISTICALLY 80112 PRELINGUISTICALLY AND AND PERILINGUISTICALL PERILINGUISTICALL Y DEAFENED ADULTS Y DEAFENED ADULTS P840060/S023 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM 7 LENSES 76134-2099 TO 5 DAYS P850021/S030 AMERICAN EDWARDS BAXTER HEALTHCARE MANUFACTURING 07/12/95 LAB., HYBRID CORPORATION MODIFICATION TO THE PERCUTANEOUS SANTA ANA, CA INNER BODY OF THE TRANSLUMINAL 92711-1150 ABOVE CATHETERS CORONARY ANGIOPLASTY CATHETER,REACH.14 ,LONG REACH 30MM & 40MM,& READY.14 PTCA CATHETERS P850029/S001 ABBOTT ER-EIA ABBOTT LABORATORIES MINOR LABELING 07/12/95 MONOCLONAL CHANGES TO ASSIST ABBOTT PARK, IL USERS IN AVOIDING 60064-3500 INTERFERENCE BY METHYLENE BLUE & SIMILAR DYES P860034/S012 MODELS AC-21 & ALLERGAN MEDICAL SINGLE-POUCH TYVEK 07/28/95 AC-21B ANTERIOR OPTICS PACKAGING OF LENSES, CHAMBER IRVINE, CA STERILIZATION OF INTRAOCULAR 92718 LENSES USING LENSES PREVIOUSLY APPROVED 100% ETO STERILIZATION CYCLES & A 5 YEAR SHELF LIFE P860047/S010 OCUCOAT STORZ OPHTHALMICS, CHANGE IN LABELING 07/18/95 VISCOELASTIC INC. FLUID CLEARWATER, FL 34619 P870018/S010 LITHOSTAR SIEMENS MEDICAL MODIFIED IMAGE 07/13/95 LITHOTRIPTER FOR SYSTEMS, INC. INTENSIFIER TO BE RENAL STONES ISELIN, NJ USED WITH THE 08830 LITHOSTAR SYSTEM P870054/S014 KELVIN MODEL 513 COOK PACEMAKER CHANGE IN ACCELERATED 07/12/95 UNIPOLAR & MODEL CORPORATION BURN-IN PROCEDURE ON 514 BIPOLAR LEECHBURG, PA THE LITHIUM/IODINE CARDIAC PULSE 15656-0529 POWER SOURCE GENERATORS (BATTERY) BY THE VENDOR P880010/S017 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS P880027/S037 SCHNEIDER SCHNEIDER (USA), INC. ADDITIONAL QUARTER 07/31/95 MICROSOFTRAC PTCA SIZE MODELS OF THE MC CATHETER, MINNEAPOLIS, MN RAIL, MYSTIC, AND SCHNEIDER MC RAIL 55442 FREEHAND CATHETER 20/30/40, MYSTIC LINES 20/30/40 MC, AND FREEHAND PTCA CATHETERS P880072/S021 MODEL PA36E-OUV MEDICAL DEVELOPMENTAL PA36E-OUV 07/28/95 ULTRAVIOLET-ABSOR RESEARCH, INC. BING POSTERIOR ST. PETERSBURG, FL CHAMBER 33716 INTRAOCULAR LENS (IOL) P880072/S026 MODELS GS55A-OUV MEDICAL DEVELOPMENTAL NEW MODELS: 07/24/95 & GS55B-OUV RESEARCH, INC. GS551A-OUV AND ULTRAVIOLET-ABSOR ST. PETERSBURG, FL GS55B-OUV AS TIER A BING POSTERIOR 33716 MODIFICATIONS OF MDL CHAMBER PA90E-2UV & FOR INTRAOCULAR IMPLANTATION IN THE LENSES (IOLS) CAPSULAR BAG ONLY P880072/S027 MODELS LP50A-OUV, MEDICAL DEVELOPMENTAL TIER A MODIFICATIONS 07/24/95 PBO6B-OUV, & RESEARCH, INC. OF A PREVIOUSLY PBO5A-OUV ST. PETERSBURG, FL APPROVED MEDICAL ULTRAVIOLET-ABSOR 33716 DEVELOPMENTAL BING POSTERIOR RESEARCH, INC., CHAMBER PARENT IOL INTRAOCULAR LENSES (IOLS) P880072/S028 MODELS LP50A-OUV, MEDICAL DEVELOPMENTAL TIER A MODIFICATIONS 07/24/95 PB06B-OUV, & RESEARCH, INC. OF A PREVIOUSLY PBO5A-OUV ST. PETERSBURG, FL APPROVED MEDICAL ULTRAVIOLET-ABSOR 33716 DEVELOPMENTAL BING POSTERIOR RESEARCH, INC., CHAMBER PARTENT IOL INTRAOCULAR LENSES (IOLS) P880072/S029 MODIFIED J & C MEDICAL DEVELOPMENTAL TIER A POSTERIOR 07/24/95 LOOP MODEL PA36 RESEARCH, INC. CHAMBER INTRAOCULAR POSTERIOR CHAMBER ST. PETERSBURG, FL LENS MODEL RM60D-2UV INTRAOCULAR LENS 33716 P880072/S032 MODELS LP50A-OUV, MEDICAL DEVELOPMENTAL TIER A MODIFICATIONS 07/24/95 PB06B-OUV, & RESEARCH, INC. OF A PREVIOUSLY PB05A-OUV ST. PETERSBURG, FL APPROVED MEDICAL ULTRAVIOLET-ABSOR 33716 DEVELOPMENTAL BING POSTERIOR RESEARCH INC., PARENT CHAMBER IOL INTRAOCULAR LENSES (IOLS) P880072/S033 MODIFIED J & C MEDICAL DEVELOPMENTAL TIER A POSTERIOR 07/24/95 LOOP MODEL PA36 RESEARCH, INC. CHAMBER INTRAOCULAR POSTERIOR CHAMBER ST. PETERSBURG, FL LENS MODEL CS55B-OUV INTRAOCULAR LENS 33716 P880081/S018 MODELS SI-18B & ALLERGAN MEDICAL SINGLE-POUCH TYVEK 07/28/95 SI-18NB OPTICS PACKAGING OF LENSES, ULTRAVIOLET-ABSOR IRVINE, CA STERILIZATION OF BING SILICONE 92718 LENSES USING POSTERIOR CHAMBER PREVIOUSLY APPROVED IOLS 100% ETO STERILIZATION CYCLES & A 5 YEAR SHELF LIFE P880087/S005 ANTERIOR AND ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS P890003/S036 MODEL 979OC MEDTRONIC, INC. UPDATED CONFIGURATION 07/31/95 PROGRAMMER AND OF THE MODEL 979OC MODEL 9877E MINNEAPOLIS, MN PROGRAMMER, & UPDATED BASELINE SOFTWARE 55432-3576 BASELINE OPERATING SOFTWARE MODEL 9877E P890043/S028 SIMPSON CORONARY DEVICES FOR VASCULAR ADDITION OF 07/12/95 ATHEROCATH INTERVENTION, INC. MANUFACTURING SITE REDWOOD CITY, CA AT TEMECULA, CA 94063 P890045/S001 GELSEAL TRIAXIAL CARBOMEDICS, INC. APPLICATION OF 07/05/95 VASCULAR GRAFT GELATIN COATING TO AUSTIN, TX VASCUSOFT, A 78752-1793 DIFFERENT SUBSTRATE GRAFT. TRADE NAME:VASCUTEK GELSOFT VASCULAR GRAFT P890056/S002 MODEL PC-28LB ALLERGAN MEDICAL SINGLE-POUCH TYVEK 07/28/95 PMMA POSTERIOR OPTICS PACKAGING OF LENSES, CHAMBER IOLS IRVINE, CA STERILIZATION OF 92718 LENSES USING PREVIOUSLY APPROVED 100% ETO STERILIZATION CYCLES & A 5 YEAR SHELF LIFE P900009/S001 SONIC ACCELERATED EXOGEN, INC. SUPPLEMENTARY 07/07/95 FRACTURE HEALING REFERENCES FOR SYSTEM (SAFHS) PISCATAWAY, NJ PHYSICIAN MODEL 2A 08855 INSTALLATION AND PATIENT USE OF THE SAFHS MODEL 2A DEVICE P900013/S001 ABBOTT PGR-EIA ABBOTT LABORATORIES MINOR LABELING 07/07/95 MONOCLONAL CHANGES TO ASSIST ABBOTT PARK, IL USERS IN AVOIDING 60064-3500 INTERFERENCE BY METHYLENE BLUE AND SIMILAR DYES P900056/S006 ROTABLATOR HEART TECHNOLOGY, INC. RELOCATION OF 07/12/95 ROTATIONAL MANUFACTURING ANGIOPLASTY REDMOND, WA FACILITY TO SYSTEM 98052-3376 REDMOND, WA P900059/S001 ALBUNEX MOLECULAR BIOSYSTEMS, TWO TRAINING VIDEOS 07/31/95 ULTRASOUND INC. CONTRAST SAN DIEGO, CA MICROSPHERES 92121-2789 P900070/S007 META DDDR CARDIAC ADDITION OF 07/12/95 PACING SYSTEM NON-INVASIVE WASHINGTON, D.C. PROGRAMMED STIMULATION 20036 (NIPS) P910001/S005 SPECTRANETICS SPECTRANETICS, INC. VITESSE-E (MODEL 07/31/95 CVX-300 EXCIMEER 117-005) AND LASER SYSTEM COLORADO SPRINGS, CO VITESSE-E II (MODEL 80907-5159 117-205) CATHETERS USED WITH THE CVX-300 EXCIMER LASER SYSTEM ON ECCENTRIC LESIONS P910001/S008 SPECTRANETICS SPECTRANETICS UPGRADED SOFTWARE 07/12/95 CVX-300 EXCIMER CORPORATION (VERSION 3.4) FOR THE LASER SYSTEM COLORADO SPRINGS, CO SPECTRANETICS CVX-300 80907 EXCIMER LASER SYSTEM P910064/S001 REALITY FEMALE WISCONSIN PHARMACAL ACCELERATED AND 07/24/95 CONDOM COMPANY REAL-TIME AGING CHICAGO, IL STUDIES TO ESTABLISH 60611 A NEW SHELF LIFE P910064/S004 REALITY FEMALE WISCONSIN PHARMACAL ADDITIONAL DATA ON IN 07/24/95 CONDOM COMPANY VITRO BARRIER CHICAGO, IL PROPERTIES W/RESPECT 60611 TO SEXUALLY TRANSMITTED DISEASES PER FDA'S 5/7/93 LTR CONTAINING CONDITIONS OF APPROVAL P910064/S006 REALITY FEMALE WISCONSIN PHARMACAL FOCUS GROUP STUDY 07/24/95 CONDOM COMPANY PROTOCOL TO ASSESS CHICAGO, IL PATIENT COMPREHENSION 60611 OF PRODUCT LABELING P910064/S007 REALITY FEMALE WISCONSIN PHARMACAL CHANGE PROFESSIONAL 07/31/95 CONDOM COMPANY MONOGRAPH & PATIENT CHICAGO, IL LABELING TO INCLUDE 60611 INFORMATION FOR CONCOMITANT USE OF SPERMICIDE CONTAINING NONOXYNOL-9 W/REALITY FEMALE CONDOM P910064/S008 REALITY FEMALE WISCONSIN PHARMACAL EXTENSION OF PRODUCT 07/31/95 CONDOM COMPANY SHELF LIFE CHICAGO, IL 60611 P910064/S009 REALITY FEMALE WISCONSIN PHARMACAL ADDITIONAL DATA ON 07/24/95 CONDOM COMPANY THE IN VITRO BARRIER CHICAGO, IL PROPERTIES W/RESPECT 60611 TO SEXUALLY TRANSMITTED DISEASES PER FDA'S 5/7/93 LTR CONTAINING CONDITIONS OF APPROVAL P910064/S010 REALITY FEMALE WISCONSIN PHARMACAL EXTENSION OF PRODUCT 07/31/95 CONDOM COMPANY SHELF LIFE CHICAGO, IL 60611 P910071/S002 ADATOSIL 5000 CHIRON VISION PROTOCOL FOR A 07/14/95 CORPORATION POSTAPPROVAL IRVINE, CA PROSPECTIVE STUDY 92718-1903 P930014/S001 ANTERIOR & ALCON LABORATORIES, REDUCTION IN 07/24/95 POSTERIOR CHAMBER INC. BIOLOGICAL INDICATOR INTRAOCULAR FORT WORTH, TX INCUBATION TIME FROM LENSES 76134-2099 7 TO 5 DAYS
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