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PMA Final Decisions Rendered for December 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.
P940033 FEMIDOM FEMALE CHARTEX INTERNATIONAL FOR USE TO HELP 04/14/95 CONDOM PLC PREVENT PREGNANCY AND LINCOLNSHIRE, IL SEXUALLY TRANSMITTED 60069-3405 DISEASES, INCLUDING HIV DURING VAGINAL INTERCOURSE IN ADULT WOMEN
N17679 /S30 PREFERENCE, COOPERVISION, INC. ADD THE MONOVISION 04/17/95 COOPERCLEAR FW, FITTING TECHNIQUE TO VANTAGETHIN, FAIRPORT, NY THE LABELING OF A VANTAGETHIN 14450 SINGLE VISION CONTACT ACCENTS LENS TO MANAGE HYDROPHILIC PRESBYOPIA LENSES N50510 /S67 VITEK GENERAL BIOMERIEUX VITEK, INC. LIMITATION STATEMENT 04/19/95 SUSCEPTIBILITY CONTRAINDICATING THE CARD HAZELWOOD, MO TESTING OF AEROMONAS 63042-2395 SP. WITH AMPICILLIN, AMPICILLIN/SULBACTUM, CEFOTETAN, CEFOXTIN, CEFOROXIME, ETC. P790005/S37 ORTHOGEN/OSTEOGEN ELECTRO-BIOLOGY, INC. CHANGE TO THE 04/06/95 IMPLANTABLE BONE STERILIZATION PROCESS GROWTH STIMULATOR PARSIPPANY, NJ AND SPF SPINAL 07054-1079 FUSION STIMULATOR P790020/S56 PERMAFLEX COOPERVISION, INC. ADD THE MONOVISION 04/17/95 NATURALS, FITTING TECHNIQUE TO PERMAFLEX UV FAIRPORT, NY THE LABELING OF A NATURALS 14450 SINGLE VISION CONTACT HYDROPHILIC LENS TO MANAGE CONTACT LENSES PRESBYOPIA P800022/S35 ZYDERM COLLAGEN COLLAGEN CORPORATION APPROVAL FOR THE 04/17/95 IMPLANT PROMOTIONAL PALO ALTO, CA LITERATURE THAT WILL 94303 ACCOMPANY ZYDERM I WITH FINE GAUGE NEEDLE P800022/S47 ADG NEEDLE COLLAGEN CORPORATION CHANGES TO THE 04/26/95 INSTRUCTIONS FOR USE PALO ALTO, CA FOR THE ADG NEEDLE TO 94303 PREVENT NEEDLE STICKS P810040/S07 SUPERSTAT SUPERSTAT, INC. RELOCATION OF THE 04/21/95 MODIFIED COLLAGEN MANUFACTURING HEMOSTATIC BONITA SPRINGS, FL FACILITY (BIOCELL SPONGES 33923 LABORATORIES) TO RANCHO DOMINGUEZ, CALIFORNIA P830055/S38 NEW JERSEY LCS DEPUY, INC. ADDITION OF ONE 04/05/95 TOTAL KNEE SYSTEM PIECE, POLYTHYLENE, WARSAW, IN FIXED BEARING, 46581-0988 POSTERIOR CRUCIATE RETAINING TIBIAL COMPONENT P830060/S36 VENTAK AICD CARDIAC PACEMAKERS, ALTERNATE 04/13/95 SYSTEM INC. STERILIZATION PROCESS ST. PAUL, MN 55112-5798 P830060/S37 VENTAK AICD CARDIAC PACEMAKERS, ALTERNATE 04/13/95 SYSTEM INC. STERILIZATION PROCESS ST. PAUL, MN 55112-5798 P840001/S34 MEDTRONIC ITREL MEDTRONIC NEUROLOGICAL SUBSTITUTION OF A 04/27/95 AND ITREL II MATERIAL USED IN THE SPINAL CORD MINNEAPOLIS, MN CONNECTOR MODULE OF STIMULATION 55440-9087 SEVERAL PULSE SYSTEM CONNECTOR GENERATORS MODULE P840008/S45 DORNIER MFL5000 DORNIER MEDICAL EXPANSION OF THE 04/12/95 LITHOTRIPTER SYSTEMS, INC INDICATION RANGE TO KENNESAW, GA INCLUDE FRAGMENTATION 30144 OF MIDDLE AND LOWER URETHRAL STONES 4 TO 9MM IN SIZE P840024/S53 NUCLEUS COCHLEAR CORPORATION USE OF ALTERNATIVE 04/17/95 22-CHANNEL HEADSET CABLES COCHLEAR IMPLANT ENGLEWOOD, CO SYSTEM 80112 P840064/S12 VISCOAT AND ALCON LABORATORIES, MODIFIED TEST REGIMEN 04/18/95 PROVISC INC. FOR FINISHED DEVICES FORT WORTH, TX 76134-2099 P840068/S23 DELTA VISTA AND CARDIAC PACEMAKERS, ALTERNATE 04/13/95 VIGOR SSI/DDD INC. STERLILIZATION PACEMAKER SYSTEMS ST. PAUL, MN PROCESS 55112-5798 P850035/S16 ORTHOGEN/OSTEOGEN ELECTRO-BIOLOGY, INC. CHANGE TO THE 04/06/95 IMPLANTABLE BONE STERILIZATION PROCESS GROWTH STIMULATOR PARSIPPANY, NJ AND SPF SPINAL 07054-1079 FUSION STIMULATOR P850077/S19 SUNSOFT SUNSOFT CORPORATION PARAMETRIC RELEASE OF 04/28/95 (METHAFILCON A) STERILIZED SOFT ALBUQUERQUE, NM METHAFILCON A CONTACT (HYDROPHILIC) 87109 LENSES APPROVED AND CONTACT LENSES LABELED FOR EXTENDED WEAR P870025/S02 COROMETRICS MODEL COROMETRICS MEDICAL LABELING CHANGE TO 04/12/95 146 FETAL SYSTEMS, INC. PERMIT INTERFACE OF ACOUSTIC WALLINGFORD, CT THE COROMETRICS MODEL STIMULATOR 06492-0333 146 FETAL ACOUSTIC STIMULATOR WITH MODELS 116, 150, 118 AND 151 FETAL MONITORS P870025/S03 COROMETRICS MODEL COROMETRICS MEDICAL LABELING CHANGE TO 04/12/95 146 FETAL SYSTEMS, INC. PERMIT INTERFACE OF ACOUSTIC WALLINGFORD, CT THE COROMETRICS MODEL STIMULATOR 06492-0333 146 FETAL ACOUSTIC STIMULATOR WITH MODELS 116, 150, 118 AND 151 FETAL MONITORS P870036/S32 EVERGREEN 40 MEDTRONIC INTERVENTION A 40 MM LONG BALLOON 04/27/95 CORONARY BALLOON VASCULAR VERSION OF THE DILATATION SAN DIEGO, CA EVERGREEN PTCA CATHETER 92121-2256 CATHETER AND ALTERNATE STRAIN RELIEF ASSEMBLY P870036/S35 MEDTRONIC 18K, MEDTRONIC INTERVEMTION REVISED LABELING 04/27/95 14K, EVERGREEN, VASCULAR FALCON, PANTHER, SAN DIEGO, CA AND SPIRIT PTCA 92121-2256 DIATATION CATHETER P880003/S36 CORDIS TITAN 18 CORDIS CORPORATION REVISED LABELING 04/27/95 PTCA DILATATION CATHETER MIAMI, FL 33102-5700 P880003/S37 CORDIS OLYMPIX II CORDIS CORPORATION REVISED LABELING 04/27/95 PTCA DILATATION CATHETER MIAMI, FL 33102-5700 P880003/S38 CORDIS PREDATOR CORDIS CORPORATION REVISED LABELING 04/27/95 XL PTCA DILATATION MIAMI, FL CATHETER 33102-5700 P880003/S39 CORDIS EUROPASS CORDIS CORPORATION REVISED LABELING 04/27/95 PTCA DILATATION CATHETER MIAMI, FL 33102-5700 P880003/S40 CORDIS TRAKSTAR CORDIS CORPORATION REVISED LABELING 04/27/95 18 PTCA DILATATION MIAMI, FL CATHETER 33102-5700 P880091/S02 ELASTIC LENS STARR SURGICAL COMPANY ELASTIC LENS MODEL 04/03/95 MODEL AA-4203V FOR SOFTLENSCO, INC. AA-4203V ULTRAVIOLET-ABSOR MONROVIA, CA ULTRAVIOLET-ABSORBING BING POSTERIOR 91016 IOL; CHIRON VISION CHAMBER CORPORATION TO INTRAOCULAR LENS DISTRIBUTE AS THE CHIROFLEX MODEL 32-C10UB IOL P890001/S12 LEOCOR PICO LEOCOR, INC. REVISED LABELING 04/27/95 RUNNER PTCA CATHETER HOUSTON, TX 77058 P890032/S20 CORDIS ORION AND CORDIS CORPORATION REVISED LABELING 04/27/95 3.5 MM ORION STEERABLE PTCA MIAMI, FL BALLOON CATHETERS 33102-5700 P890045/S05 VASCUTEK GELSEAL CARBOMEDICS, INC. LABELING CHANGE TO 04/13/95 VASCULAR GRAFT ADD A STATEMENT AUSTIN, TX RELATING TO BOVINE 78752 SPONGIOFORM ENCEPHALOPATHY P890047/S05 MODIFIED TEST ALCON LABRATORIES, MODIFIED TEST REGIMEN 04/18/95 REGIMEN FOR THE INC. FOR FINISHED DEVICES RELEASE OF FORT WORTH, TX VISCOAT AND 76134-2099 PROVISC P890061/S09 VENTAK P AICD CARDIAC PACEMAKERS, ALTERNATE 04/11/95 SYSTEM INC. STERILIZATION PROCESS ST. PAUL, MN 55112-5798 P890064/S03 VIRATYPE HUMAN DIGENE DIAGNOSTICS, RNA:DNA SANDWICH 04/28/95 PAPILLOMAVIRUS INC. CAPTURE (ANTIBODY) (HPV) DNA TYPING SILVER SPRING, MD ENZYMATIC KIT 20904 CHEMILUMINESCENT MOLECULAR HYBRIDIZATION ASSAY WITH THE NEW TRADE NAME HYBRID CAPTURE P900056/S10 ROTABLATOR HEART TECHNOLOGY PACKAGING INSERT FOR 04/27/95 ROTATIONAL THE A AND C TYPE ANGIOPLASTY REDMOND, WA GUIDEWIRES SYSTEM 98052 P900061/S10 MEDTRONIC MEDTRONIC, INC. LABELING CHANGES 04/27/95 IMPLANTABLE REGARDING CELLULAR CARDIOVERTER MINNEAPOLIS, MN PHONES DEFIBRILLATORS 55432-3576 MODEL: 7217B/D-PCD, 7201B/D-PCD CD, 7219B/D/E-JEWEL, 7202D/E-JEWEL CD P910020/S08 RELAY MODELS INTERNEDICS, INC. CHANGE IN THE 04/27/95 294-03/293-03, MANUFACTURE OF THE DASH MODELS ANGLETON, TX MICROELECTRONIC 291-03/292-03/292 77515 HYBRIDS -03R, STRIDE MODEL 294-05, AND DART MODEL 292-05 P910023/S10 CADENCE TIERED VENTRITEX, INC. LABELING CHANGES IN 04/27/95 THERAPY THE PATIENT MANUAL DEFIBRILLATOR SUNNYVALE, CA SYSTEM 94086-6527 P910073/S03 ENDOTAK SQ LEAD CARDIAC PACEMAKERS, ENDOTAK SQ LEAD ARRAY 04/17/95 ARRAY MODEL 0048 INC. MODEL 0048 AND ST. PAUL, MN ACCESSORY KIT MODEL 55112-5798 6927 P910073/S08 ENDOTAK ST. PAUL, MN ALTERNATE 04/13/95 TRANSVENOUS STERILIZATION PROCESS DEFIBRILLATION ST. PAUL, MN LEAD SYSTEM 55112-5798 P910073/S10 ENDOTAK CARDIAC PACEMAKERS, ALTERNATE 04/13/95 TRANVENOUS INC. MANUFACTURING DEFIBRILLATION ST. PAUL, MN STERILIZATION PROCESS LEAD SYSTEM 55112-5798 P910073/S11 ENDOTAK C 0060 CARDIAC PACEMAKERS, DESIGN CHANGES TO THE 04/27/95 AND 0070 SERIES INC. ENDOTAK C 0060 AND LEADS ST. PAUL, MN 0070 SERIES LEADS 55112-5798 P910075/S01 WESLEY-JESSEN ALLERGAN OPTICAL CHANGE THE MAXIMUM 04/28/95 MULTI-PURPOSE RECOMMENDED STORAGE SOLUTION IRVINE, CA TIME ON THE LABEL 92713-9534 FROM 7 DAYS TO 30 FOR THE LENS WEARER'S STORAGE OF LENSES P910077/S06 VENTAK PRX AICD CARDIAC PACEMAKERS, ALTERNATE 04/13/95 SYSTEM INC. STERILIZATION PROCESS ST. PAUL, MN 55112-5798 P940013/S04 PRECISION UV PILKINGTON BARNES-HIND LABELING CHANGES TO 04/19/95 (VASURFILCON) INCLUDE DISPOSABLE SOFT SUNNYVALE, CA WEARING INSTRUCTIONS (HYDROPHILIC) 94086-5200 CONTACT LENSES (CLEAR AND TINTED)
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