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PMA Final Decisions Rendered for March 1996 |
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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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