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Medical Devices
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April 1995 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for December 1995. This list is generated on a monthly basis.
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.
PMA Original Approvals
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
PMA Supplement Approvals
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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