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Medical Devices
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July 1995 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for July 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
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)
PMA Supplement Approvals
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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