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PMA Final Decisions Rendered for December 1995 |
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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.
P870072 THORATEC ADVANCED BIORESEARCH INTENDED AS A BRIDGE
12/20/95 VENTRICULAR ASSOCIATES TO CARDIAC
ASSIST DEVICE ROCKVILLE, MD TRANSPLANTATION FOR
(VAD) SYSTEM 20852-1631 USE IN PATIENTS
SUFFERING FROM
END-STAGE HEART
FAILURE
P940010 OPTIGUIDE QLT PHOTOTHERAPEUTICS, APPROVAL FOR
12/27/95 FIBER OPTIC INC. OPTIGUIDE FIBER OPTIC
DIFFUSER, SEATTLE, WA DIFFUSER, MODELS DCYL
MODELS DCYL 10, 98101 10, DCYL 15, AND
DCYL 15, AND DCYL 25 FOR USE WITH
DCYL 25 PHOTOFRIN FOR
PALLIATION ESOPHAGEAL
CANCER
P940011 COHERENT PDL1 QLT PHOTOTHERAPEUTICS, COHERENT PDL1 AND
12/27/95 AND PDL2 LAMBDA INC. PDL2 LAMBDA PLUS
PLUS SEATTLE, WA PHOTODYNAMIC LASERS
PHOTODYNAMIC 98101 FOR USE WITH
LASERS PHOTOFRIN FOR
PALLIATION ESOPHAGEAL
CANCER
P940012 600 SERIES DYE QLT PHOTOTHERAPEUTICS, 600 SERIES DYE
12/27/95 MODULES (MODELS INC. MODULES (MODELS 630
630 AND 630 XP) SEATTLE, WA AND 630XP) AND SERIES
AND SERIES 700 98101 700 AND 800 KTP/532
AND 800 KTP/532 AND KTP/YAG
AND KTP/YAG (OPERATING AT 532NM)
SURGICAL LASERS SURGICAL LASERS FOR
USE WITH PHOTOFRIN
P940034 GEN-PROBE GEN-PROBE INC. FOR USE AS AN
12/15/95 AMPLIFIED ADJUNCTIVE TEST FOR
MYCOBACTERIUM SAN DIEGO, CA EVALUATING AFB SMEAR
TUBERCULOSIS 92121 POSITIVE CONCENTRATED
DIRECT TEST SEDIMENTS FROM
UNTREATED PATIENTS
SUSPECTED OF HAVING
TB
P950021 TECHNICON IMMUNO BAYER CORPORATION APPROVAL FOR THE
12/22/95 1 PSA ASSAY TECHNICON IMMUNO 1
TARRYTOWN, NY PSA ASSAY - THIS
10591 DEVICE IS AN IN VITRO
DIAGNOSTIC DEVICE
N17600 /S013 AVITENE MEDCHEM PRODUCTS, ALTERNATIVE FINISHED
12/27/95 MICROFIBRILLAR INC. DEVICE FACILITY AT
COLLAGEN HEMOSTAT WOBURN, MA WOBURN, MA 01801
(MCH) 01801
P790018/S026 MEDTRONIC HALL MEDTRONIC, INC. APPROVAL FOR 100% ETO
12/07/95 PROSTHETIC HEART STERILIZATION
VALVE MINNEAPOLIS, MN
55440
P800049/S007 IRIDOCAPSULAR ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 INTRAOCULAR INC. ALTERNATE
LENS FORT WORTH, TX STERILIZATION PROCESS
76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P810001/S012 ANTERIOR CHAMBER ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 INTRAOCULAR LENS INC. ALTERNATE
FORT WORTH, TX STERILIZATION PROCESS
76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P810018/S035 UV ABSORBING ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 POSTERIOR CHAMBER INC. ALTERNATE
INTRAOCULAR LENS FORT WORTH, TX STERILIZATION PROCESS
76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P810032/S048 UV ABSORBING ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 POSTERIOR INC. ALTERNATE
CHAMBER FORT WORTH, TX STERILIZATION PROCESS
INTRAOCULAR LENS 76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P810046/S157 ACS SIMPSON- ADVANCED APPROVAL FOR THE ACS
12/05/95 ROBERT CORONARY CARDIOVASCULAR OTW LIFESTREAM
DILATATION SANTA CLARA, CA CORONARY DILATATION
CATHETER 95052-8167 CATHETER
P810046/S160 SIMPSON-ROBERT ADVANCED MODIFICATIONS OF THE
12/28/95 PTCA CATHETER CARDIOVASCULAR INFLATION/DEFLATION
ACS RX LIFESTREAM TEMECULA, CA NOTCH AND CHANGES TO
AND ACS OTW 92591-4628 THE GUIDE WIRE EXIT
LIFESTREAM PTCA NOTCH AND PROXIMAL
CATHETERS ADAPTION VISUAL
INSPECTION CRITERIA
P820001/S018 OPTI-FREE ALCON LABORATORIES APPROVAL FOR A
12/28/95 SUPRA-CLENS DAILY PANCREATIN-BASED
PROTEIN REMOVER FORT WORTH, TX LIQUID ENZYMATIC
76134-2099 CLEANER
P820021/S025 NEWVUES, NEWVUES CIBA VISION, ALTERNATE
12/13/95 SOFTCOLORS, CORPORATION MANUFACTURING SITE
FOCUS, FOCUS DULUTH, GA TO MAKE SOFT CONTACT
VISITINT, AND 30136-1518 LENS BLANKS
FOCUS SOFTCOLORS
(VIFILCON A) SOFT
(HYDROPHILIC)
CONTACT LENSES
P820035/S014 ANTERIOR CHAMBER ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 INTRAOCULAR INC. ALTERNATE
LENS FORT WORTH, TX STERILIZATION PROCESS
76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P820040/S033 AOSEPT CIBA VISION, APPROVAL FOR LABELING
12/13/95 DISINFECTANT CORPORATION MODIFICATIONS IN THE
DULUTH, GA PACKAGE INSERT
30136-1518
P820060/S009 ABBOTT AXSYM AFP ABBOTT LABORATORIES MODIFICATION OF THE
12/26/95 POTENCY TEST FOR THE
ABBOTT PARK, IL ANTI-AFP: ALKALINE
60064-3500 PHOSPHATASE CONJUGATE
P820076/S020 BIOTRONIK GEMNOS BIOTRONIK, INC. APPROVAL FOR THE
12/22/95 AND GEMNOS 04, CHANGE IN THE BURN-IN
O4A, AND TC 04 LAKE OSWEGO, OR PROCESSING OF THE
97035-5369 WILSON GREATBATCH
BATTERIES REDUCTION
OF BATTERY BURN-IN
TIME FROM 35 DAYS
TO 4 DAYS
P830040/S025 3M VISION CARE ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 POSTERIOR CHAMBER INC. ALTERNATE
INTRAOCULAR LENS FT. WORTH, TX STERILIZATION PROCESS
76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P830055/S042 NEW JERSEY LCS DEPUY, INC. APPROVAL OF MINIMUM
12/13/95 TOTAL KNEE SYSTEM DOSE GAMMA
WARSAW, IN IRRADIATION
46581-0988 VALIDATION FOR
POLYETHYLENE
COMPONENTS
P830055/S044 ROTATING PLATFORM DEPUY, INC. APPROVAL FOR THE
12/28/95 CONFIGURATION OF ADDITION OF SMALL AND
THE NEW JERSEY WARSAW, IN SMALL+ SIZED BEARING
LCS TOTAL KNEE 46581-0988 COMPONENTS
SYSTEM
P840001/S038 MODEL 7495, MEDTRONIC APPROVAL FOR THE USE
12/06/95 ITREL II NEUROLOGICAL OF SEALING RINGS IN
PERMANENT MINNEAPOLIS, MN THE MODEL 7495
EXTENSION 55440-9087 PERMANENT EXTENSION
P840024/S059 NUCLEUS 22 COCHLEAR CHANGES TO THE
12/11/95 CHANNEL COCHLEAR CORPORATION INTEGRATED CIRCUIT
IMPLANT SYSTEM ENGLEWOOD, CO (IC) TEST SOFTWARE
80112 (K15001) IN ORDER
TO ADD SEVERAL TESTS
OF IMPROVED QUALITY
ASSURANCE
P840060/S024 POSTERIOR CHAMBER ALCON LABORATORIES, APPROVAL FOR AN
12/13/95 INTRAOCULAR LENS INC. ALTERNATE
FORT WORTH, TX STERILIZATION PROCESS
76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P850064/S011 MODEL 203 LIFE BUNNELL, INC. ADDITION OF AN
12/18/95 PULSE HIGH ENDOTRACHEAL TUBE
FREQUENCY JET SALT LAKE CITY, UT ADAPTER - TRADE NAME:
VENTILATOR 84115 "LIFEPORT"
P850089/S033 CAPSURE Z MEDTRONIC, INC. NEW MODELS:
12/21/95 MODELS 5034/ CAPSURE Z 5035,
5534/5033 MINNEAPOLIS, MN 5534, AND 5033
PACING LEADS 55432-3576 PACING LEADS
P860019/S094 SCIMED PTCA SCIMED LIFE SYSTEMS, APPROVAL FOR A CHANGE
12/07/95 CATHETERS INC. IN STERILIZATION
MAPLE GROVE, MN PROCESS FROM 12/88
55311-1566 ETHYLENE OXIDE/CFC-12
TO 8.6/91.6 OXYFUME
2000 MIXTURE
P870036/S037 VERSAFLEX MEDTRONICS ALTERNATE ADHESIVE
12/07/95 BUCHBINDER INTERVENTIONAL FOR PTCA CATHETERS
OMNIFLEX PTCA SAN DIEGO, CA
CATHETER SYSTEM 92121-2256
MEDTRONIC 18K,
18K WITH TIP
MARKER, 14K, 14K
LONG, PANTHER,
PANTHER 30, AND
PANTHER 40 PTCA
CATHETERS
P880003/S050 CORDIS PTCA CORDIS CORPORATION MODIFICATION OF THE
12/05/95 DILATATION EXIT MARKER MATERIAL
CATHETER MIAMI, FL AND APPLICATION
CORDIS TITAN 33102-5700 PROCESS
18 PTCA
DILATATION
CATHETER AND
TITAN XL PTCA
DILATATION
CATHETER
P880003/S051 CORDIS CORDIS CORPORATION ALTERNATE
12/06/95 PTCA DILATION STERILIZATION SITE
CATHETERS MIAMI, FL (ISOMEDIX)
33102-5700 NORTHBOROUGH,
MASSACHUSETTS
P880010/S018 POSTERIOR ALCON LABORATORIES APPROVAL FOR AN
12/13/95 CHAMBER ALTERNATE
INTRAOCULAR FORT WORTH, TX STERILIZATION PROCESS
LENS 76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF
THE BIOLOGICAL
INDICATOR INCUBATION
P880028/S003 DEXTRAN HM 32% ABBOTT LABORATORIES APPROVAL FOR DELETING
12/15/95 HYSTEROSCOPIC THE TEST FOR
DISTENTION ABBOTT PARK, IL ANTIGENIC IMPURITIES
MEDIUM 60064-3537 IN THE TESTING
SPECIFICATIONS FOR
THE DEXTRAN 70 (CODE
59479) BULK DRUG
SUBSTANCE
P880087/S006 ANTERIOR CHAMBER ALCON LABORATORIES APPROVAL FOR AN
12/13/95 INTRAOCULAR ALTERNATE
LENS FORT WORTH, TX STERILIZATION PROCESS
76134-2099 INCLUDING AERATION
TIME AND THE
ESTABLISHMENT OF THE
BIOLOGICAL INDICATOR
INCUBATION TIME
P890003/S041 MEDTRONIC MEDTRONIC, INC. ALTERNATE
12/06/95 SYNERGYST II STERILIZATION
PULSE GENERATOR MINNEAPOLIS, MN PROCESS
SYSTEM 55432-3576
P890027/S028 NUCLEUS 22 COCHLEAR ADDITIONAL QUALITY
12/11/95 CHANNEL COCHLEAR CORPORATION ASSURANCE PROVISIONS
IMPLANT SYSTEM ENGLEWOOD, CO DURING TESTING OF
80112 THE MINI 22 COCHLEAR
IMPLANT FOR THE
NUCLEUS 22-CHANNEL
COCHLEAR IMPLANT
SYSTEM
P890034/S005 MODEL 1010 INFRASONICS, INC. APPROVAL FOR AN
12/28/95 ULTRAHIGH PROXIMAL MONITORING
FREQUENCY SAN DIEGO, CA ENDOTRACHEAL TUBE
VENTILATOR 92121-1402 ADAPTER FOR USE WITH
THE ADULT STAR MODEL
1010 ULTRAHIGH
FREQUENCY VENTILATOR
P900052/S003 PORT-A-CATH SIMS DELTEC, INC. ADDITION OF A 16
12/21/95 INTRASPINAL GAUGE, THIN-WALL
IMPLANTABLE ST PAUL, MN INTRODUCER NEEDLE
ACCESS SYSTEM 55112 (MANAN EPIDURAL
NEEDLE (K852428)) TO
THE PORT-A-CATH
EPIDURAL IMPLANTABLE
P900061/S014 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR THE
12/06/95 7219C/7202C MEDTRONIC MODEL
JEWEL ACTIVE CAN MINNEAPOLIS, MN 7219C/7202C JEWEL
MANAGEMENT 55432-3576 ACTIVE CAN ARRHYTHMIA
SYSTEMS MANAGEMENT SYSTEMS
P900061/S020 MEDTRONIC MODEL MEDTRONIC, INC. APPROVAL FOR MED REL,
12/14/95 7219B, 7219E, AND ROAD 909, KM.0.4,
7202E ARRHYTHMIA MINNEAPOLIS, MN BARRIO MARIANA,
MANAGEMENT 55432-3576 HUMACAO, PUERTO RICO
DEVICES 00661 TO MANUFACTURE
THE MODELS 7219B,
7219E, AND 7202E
P910016/S005 UNICOMPARTMENTAL DEPUY INC. APPROVAL OF MINIMUM
12/13/95 DEVICE DOSE GAMMA
CONFIGURATION OF WARSAW, IN IRRADIATION
THE NEW JERSEY 46581-0988 VALIDATION FOR
LCS TOTAL KNEE POLYETHYLENE
SYSTEM COMPONENTS
P910016/S006 UNICOMPARTMENTAL DEPUY INC. APPROVAL OF ETHYLENE
12/13/95 DEVICE OXIDE STERILIZATION
CONFIGURATION OF WARSAW, IN FOR POLYETHYLENE
THE NEW JERSEY 46581-0988 COMPONENTS
LCS TOTAL KNEE
SYSTEM
P910023/S012 CADET V-105 "C" VENTRITEX, INC. APPROVAL FOR CADENCE
12/22/95 AND "D" AND TIERED THERAPY
V-115 "C" AND SUNNYVALE, CA DEFIBRILLATOR SYSTEM
"D" PULSE 94086-6527 WITH "C" AND "D"
GENERATORS, AND HEADER STYLES
SOFTWARE VERSION
4.1 FOR THE
PROGRAMMER MODEL
PR-1500
P910031/S003 CATHSCANNER ENDOSONICS CORP. APPROVAL FOR THE
12/07/95 ORACLE MICRO ENDOSONICS ORACLE
PTCA CATHETER RANCHO CORDOVA, CA FOCUS PTCA CATHETER,
95670 AS MODIFIED WILL BE
MARKETED UNDER THE
TRADE NAME ENDOSONICS
ORACLE FOCUS PTCA
CATHETER
P910058/S007 MODEL C11UB CHIRON VISION CORP. APPROVAL FOR MODEL
12/14/95 ULTRAVIOLET- C11UB
ABSORBING CLAREMONT, CA ULTRAVIOLET-ABSORBING
SILICONE 91711 POSTERIOR CHAMBER
POSTERIOR INTRAOCULAR LENS
CHAMBER
INTRAOCULAR LENS
P910075/S004 COMPLETE BRAND ALLERGAN OPTICAL APPROVAL FOR THE
12/05/95 LUBRICATING AND FOLLOWING ALTERNATE
REWETTING DROPS IRVINE, CA MANUFACTURING
92713-9534 SITE:ALLERGAN
AMERICA, PUERTO RICO
ROAD 345 KM 1.5,
HORMIGUEROS, PUERTO
RICO, 00660
P910077/S008 VENTAK MINI GUIDANT CORPORATION APPROVAL FOR THE
12/21/95 AICD SYSTEM VENTAK MINI AICD
ST. PAUL, MN SYSTEM, WHICH
55112-5798 INCLUDES:MODEL
NUMBERS 1645, 1740,
1741, 1745, AND 1746
PULSE GENERATORS;
MODEL 2840 SOFTWARE
P920015/S008 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR USE OF
12/07/95 TRANSVENE LEAD AN ALTERNATE
SYSTEM MINNEAPOLIS, MN STERILIZATION PROCESS
55432-3576 AND A MODIFICATION TO
THE DISTAL END OF THE
TRANSVENE LEADS
P920030/S001 CIBA CORNING ACS CIBA-CORNING CHANGE IN THE METHOD
12/13/95 PSA IMMUNOASSAY DIAGNOSTICS OF STANDARDIZATION
MEDFIELD, MA OF THE CALIBRATORS
02052-1688 FOR THE ASSAY
P920051/S001 STORZ MODULITH KARL STORZ APPROVAL FOR A MOBILE
12/19/95 LITHOTRIPTER LITHOTRIPSY-AMERICA, VERSION OF THE STORZ
MODEL SL20 CULVER CITY, CA MODULITH
90230-7600 LITHOTRIPTER, MODEL
SL20
P920051/S002 STORZ MODULITH KARL STORZ INCLUSION OF AN
12/11/95 LITHOTRIPTER, LITHOTRIPSY-AMERICA, UPGRADED VIDEO
SL20 KENNESAW, GA MIXER AND A
30144 MODIFICATION OF THE
WATER CIRCUIT TO
INCLUDE PRESSURE
Updated 8/1/1997
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