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PMA Final Decisions Rendered for January 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.
N17600 /S12 AVITENE MEDCHEM PRODUCTS, INC. MODIFIED
01/20/95 MICROFIBRILLAR STERILIZATION
COLLAGEN HEMOSTAT WOBURN, MA CONDITIONS. TRADE
(MCH) 01801 NAME:SYRINGE AVITENE.
INDICATED FOR
SURGICAL PROCEDURES
AS AN ADJUNCT TO
HEMOSTASIS
P810055/S55 MODEL 820A PHARMACIA INC., APPROVAL FOR MODEL
01/27/95 POSTERIOR CHAMBER OPHTHALMICS 820A POSTERIOR
INTRAOCULAR MONROVIA, CA CHAMBER INTRAOCULAR
LENSES (IOLS) 91017-7136 LENSES
P810055/S56 ONE-PIECE PHARMACIA INC., APPROVAL TO
01/05/95 (NON-CM) OPHTHALMICS MANUFACTURE DEVICES
POSTERIOR CHAMBER MONROVIA, CA APPROVED UNDER THIS
INTRAOCULAR 91017-7136 PMA AT AN ALTERNATE
LENSES (IOLS) MANUFACTURING SITE,
PHARMACIA PRODUCTION,
B.V., GRONINGEN, THE
NETHERLANDS.
P810055/S57 MODEL 727A PHARMACIA INC., ALTERNATE
01/05/95 POSTERIOR CHAMBER OPHTHALMICS MANUFACTURING SITE &
INTRAOCULAR MONROVIA, CA IMPLEMENT CEEON
LENSES (IOLS) 91017-7136 LABELING WITH CM
FEATURE MANUFACTURED
BY STRETCH OR
COMPRESSION-MOLDING
PROCESSES
P810055/S58 MODEL 734A PHARMACIA INC., ALTERNATE
01/05/95 POSTERIOR OPHTHALMICS MANUFACTURING SITE &
CHAMBER MONROVIA, CA IMPLEMENT CEEON
INTRAOCULAR 91017-7136 LABELING WITH CM
LENSES (IOLS) FEATURE MANUFACTURED
BY STRETCH OR
COMPRESSION-MOLDING
PROCESSES
P810055/S59 ONE-PIECE CM PHARMACIA INC., ALTERNATE
01/05/95 POSTERIOR CHAMBER OPHTHALMICS MANUFACTURING SITE
INTRAOCULAR MONROVIA, CA LOCATED IN GRONINGEN,
LENSES (IOLS) 91017-7136 THE NETHERLANDS
P810055/S61 MODEL 809F PHARMACIA INC., APPROVAL FOR MODEL
01/27/95 ULTRAVIOLET-ABSOR OPHTHALMICS 809F POSTERIOR
BING POSTERIOR MONROVIA, CA CHAMBER INTRAOCULAR
CHAMBER 91017-7136 LENSES.
INTRAOCULAR
LENSES (IOLS)
P820003/S69 VERSATRAX PACING MEDTRONIC, INC. MODIFICATIONS TO THE
01/23/95 SYSTEM MEMORY MODULE
MINNEAPOLIS, MN (MEMMOD) MODELS 7455,
55432-3576 9725, 9737, 9742,
9743,9746A, 9748,
9749, 9757, 9780,
9781, 9788, 9789, &
9791
P820083/S19 ULTEX EPTFE W.L. GORE & ASSOCIATES ADDITION OF U.S.P.
01/23/95 SUTURE SIZES TO EXISTING
FLAGSTAFF, AZ LINE OF GORE-TEX
86003-2300 EPTFE SUTURES. TRADE
NAME:ULTEX. INDICATED
FOR USE IN ALL TYPES
OF SOFT TISSUE
APPROXIMATIONS
P830026/S62 COSMOS II PACING INTERMEDICS, INC. APPROVAL FOR PROGRAM
01/23/95 SYSTEM SOFTWARE MODULE AND
ANGLETON, TX LABELING CHANGES
77515
P830026/S63 COSMOS FAMILY OF INTERMEDICS, INC. USE OF WILSON
01/23/95 PULSE GENERATORS GREATBATCH BATTERIES
ANGLETON, TX WHICH HAVE UNDERGONE
77515 A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P830045/S49 AFP CARDIAC PACESETTER, INC. USE OF WILSON
01/05/95 PACING SYSTEM GREATBATCH BATTERIES
SYLMAR, CA WHICH HAVE UNDERGONE
91392-9221 A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P830055/S35 NEW JERSEY LCS DEPUY, INC. ADDITION OF A ONE
01/18/95 TOTAL KNEE SYSTEM PIECE, POLYETHYLENE,
WARSAW, IN FIXED BEARING,
46581-0988 POSTERIOR CRUCIATE
SACRIFICING, TIBIAL
COMPONENT OPTION
P830061/S23 CAPSURE SP PACING MEDTRONIC, INC. MODIFICATIONS TO THE
01/31/95 LEAD MODELS 4023, CAPSURE SP PACING
4024, & 4524 MINNEAPOLIS, MN LEAD MODELS 4023, 4024,
55432-3576 AND 4524
P840001/S31 MEDTRONIC ITREAL MEDTRONIC NEUROLOGICAL USE OF PELLETHANE 75D
01/05/95 SPINAL CORD AGED MORE THAN 2
STIMULATION MINNEAPOLIS, MN YEARS IN THE
SYSTEM 55440-9087 CONNECTOR MODULES OF
ITREL I & II SPINAL
CORD STIMULATORS
P840001/S35 ITREL & ITREL MEDTRONIC, INC. MODIFICATIONS TO THE
01/23/95 SPINAL CORD MEMORY MODULE
STIMULATION MINNEAPOLIS, MN (MEMMOD) MODLES 7455,
SYSTEMS 55432-3576 9725, 9737, 9742,
9743, 9746A, 9748,
9749, 9757, 9780,
9781, 9788, 9789, AND
9791
P840039/S45 MODEL P54OUV STORZ OPHTHALMICS, APPROVAL FOR MODEL
01/10/95 ULTRAVIOLET-ABSOR INC. P54OUV
BING POSTERIOR CLEARWATER, FL ULTRAVIOLET-ABSORBING
CHAMBER 34619 POSTERIOR CHAMBER
INTRAOCULAR LENS LENS
(IOL)
P840040/S42 MEDITECH CORONARY BOSTON SCIENTIFIC ADDITION OF
01/23/95 BALLOON DILATION CORPORATION` PROFESSIONAL CONTRACT
SYSTEM NATICK, MA STERILIZATION AS A
01760-1537 CONTRACT STERILIZER
TO STERILIZE BSC PTCA
CATHETERS USING NEW
100% ETO
STERILIZATION CYCLE
P850051/S41 ACTIVITRAX MEDTRONIC, INC. CHANGE IN THE SHELF
01/31/95 PACING SYSTEM LIFE FOR PELLETHANE
MINNEAPOLIS, MN 75D FROM THE CURRENTLY
55432-3576 SPECIFIED 2 TO 5 YEARS
P850051/S46 MEDTRONIC LEGEND MEDTRONIC, INC. MARKET TWO MODELS OF
01/05/95 II PULSE PACEMAKERS UNDER AN
GENERATOR MODELS MINNEAPOLIS, MN ADDITIONAL BRAND NAME
8424, 8426, & 55432-3576 AND MODEL NUMBERS
8427
P850051/S48 MEDTRONIC SINGLE MEDTRONIC, INC. USE OF AN ALTERNATIVE
01/05/95 CHAMBER SHIELD FINISH FOR THE
PACEMAKERS MINNEAPOLIS, MN MINIX MODELS 8340,
55432-3576 8341, 8342, 8341M AND
MINIXST MODELS 8330,
8331, & 8331M
P850051/S49 MEDTRONIC SINGLE MEDTRONIC, INC. USE OF THE UNCOATED
01/05/95 CHAMBER PETG PACKAGING
PACEMAKERS MINNEAPOLIS, MN MATERIAL FOR THE
55432-3576 MINIX MODELS 8340,
8341, 8342, 8341M AND
MINIXST MODELS 8330,
8331, AND 8331M
P850089/S30 STERX TIP PACING MEDTRONIC, INC. ADDITION OF NEW STYLET
01/31/95 LEAD MODELS 5025 TO STERILE PACKAGE OF
AND 5525 MINNEAPOLIS, MN MDLS 5023M & 4162 LEADS
CAPSURE SP MODEL 55432-3576 UPGRADE OF STAINLESS
5023M & CPI STEEL COMPONENTS TIP
DEXATIP MODEL 316L VAR & DESIGN
4162 PACING CHANGES TO MDLS 5023M
LEADS & 4162 LEADS
P860003/S23 UVAR THERAKOS, INC. CHANGE IN LOCATION OF
01/26/95 PHOTOPHERESIS MANUFACTURING
SYSTEM WEST CHESTER, PA FACILITY FOR THE
19380 CONTRACT
MANUFACTURER, LYDO
PRECISION PRODUCTS,
WHICH MANUFACTURERS
THE UVAR INSTRUMENT
P860007/S11 INTERTACH II INTERMEDICS, INC. APPROVAL FOR EXTERNAL
01/18/95 MODEL 262-16X USE OF INTERTACH II
ANGLETON, TX MODEL 262-16X
77515
P860019/S95 SCIMED PTCA SCIMED LIFE SYSTEMS, APPROVAL FOR EXPRESS
01/23/95 CATHETERS SCIMED INC. PLUS II PERCUTANEOUS
EXPRESS PLUS II MAPLE GROVE, MN TRANSLUMINAL CORONARY
PTCA CATHETER 55311-1566 ANGIOPLASTY CATHETER
P860019/S96 SCIMED PTCA SCIMED LIFE SYSTEMS, MODIFICATION TO THE
01/05/95 CATHETERS TRAPPER INC. PACKAGING FOR TRAPPER
EXCHANGE DEVICE PLYMOUTH, MN EXCHANGE DEVICE
55441-2644
P870015/S19 MEDSTONE STS MEDSTONE NEW MANUFACTURING
01/06/95 EXTRACORPOREAL INTERNATIONAL, INC. FACILITY (MEDSTONE
SHOCK WAVE ALISO VIEJO, CA INTERNATIONAL, INC.,
LITHOTRIPTER 92656 ALISO VIEJO, CA.)
P870073/S12 THREE-PIECE STORZ OPHTHALMICS, APPROVAL FOR MODELS
01/26/95 POSTERIOR CHAMBER INC. P453UV & P454UV
INTRAOCULAR CLEARWATER, FL POSTERIOR CHAMBER
LENSES 34619 IOLS & THREE-PIECE
POSTERIOR CHAMBER
IOLS
P880003/S34 OLYMPIX II CORDIS CORPORATION TRADE NAME CHANGE TO
01/05/95 PTCA DILATATION OLYMPIX II PTCA
CATHETER MIAMI, FL DILATATION CATHETER
33102-5700
P880006/S17 MULTILOG MODELS SIEMENS PACESETTER, APPROVAL FOR MULTILOG
01/12/95 2040T AND 2040K INC. MODELS 2040T AND
PULSE GENERATORS SYLMAR, CA 2040K PULSE
91392-9221 GENERATORS
P880070/S4 MODEL UV65 SERIES PHARMACIA INC., APPROVAL TO
01/23/95 ULTRAVIOLET-ABSOR OPHTHALMICS MANUFACTURE ANTERIOR
BING ANTERIOR MONROVIA, CA CHAMBER INTRAOCULAR
CHAMBER 91017-7136 LENSES APPROVED UNDER
INTRAOCULAR THIS PMA AT AN
LENSES ALTERNATE
MANUFACTURING SITE
(GRONINGEN)
P880081/S17 MODEL SI-11NB ALLERGAN MEDICAL APPROVAL FOR MODEL
01/18/95 ULTRAVIOLET-ABSOR OPTICS, INC. SI-11NB
BING SILICONE IRVINE, CA ULTRAVIOLET-ABSORBING
POSTERIOR CHAMBER 92718 SILICONE POSTERIOR
INTRAOCULAR LENS CHAMBER INTRAOCULAR
(IOL) LENS
P880086/S26 SYNCHRONY CARDIAC PACESETTER, INC. FDA APOLOGIZES FOR
01/05/95 PACING SYSTEM INCORRECTLY
PARAGON III SYLMAR, CA IDENTIFYING THE
MODELS 2314L, 91392-9221 MODELS COVERED IN OUR
2314T, AND 10/31/94 APPROVAL
2315M/S LETTER. THE CORRECT
MODEL NUMBER SHOULD
HAVE BEEN "2314T"
P880086/S30 SYNCHRONY CARDIAC PACESETTER, INC. USE OF WILSON
01/23/95 PACING SYSTEM GREATBATCH BATTERIES
SYLMAR, CA WHICH HAVE UNDERGONE
91392-9221 A MODIFIED
ACCELERATED BURN-IN
PROCEDURE FOR
ACCEPTANCE TESTING
P890003/S25 SYNERGYST II MEDTRONIC, INC. CHANGE IN SHELF LIFE
01/31/95 PACING SYSTEM FOR PELLETHANE 75D
MINNEAPOLIS, MN FROM THE CURRENTLY
55432-3576 SPECIFIED 2 TO 5 YEARS
P890003/S28 MODEL 9870A MEDTRONIC, INC. APPROVAL FOR MODEL
01/11/95 SOFTWARE 9870A SOFTWARE
DISKETTES MINNEAPOLIS, MN DISKETTES
55432-3576
P890003/S31 THERA DR MODELS MEDTRONIC, INC. APPROVAL FOR THERA
01/10/95 ("SERIES 40"), DR FAMILY OF PULSE
MODELS ("SERIES MINNEAPOLIS, MN GENERATORS ASSOCIATED
50"), D MODELS, 55432-3576 PROGRAMMING SOFTWARE
SR MODELS, S MODELS REFERENCED
MODELS PULSE
GENERATORS, MODEL
9875E/A SOFTWARE,
MODEL 9757
MEMORYMOD
P890003/S33 MEDTRONIC ELITE MEDTRONIC, INC. APPROVAL FOR
01/05/95 II PULSE PERMISSION TO MARKET
GENERATOR MODELS MINNEAPOLIS, MN TWO MODELS OF
7084, 7085, AND 55432-3576 PACEMAKERS UNDER AN
7086 ADDITIONAL BRAND NAME
AND MODEL NUMBERS
P890043/S26 SIMPSON CORONARY DEVICES VASCULAR APPROVAL FOR GRAFT &
01/31/95 ATHEROCATH INTERVENTION, INC. LARGE GRAFT SIZES OF
ATHEROCATH-GTO REDWOOD CITY, CA ATHEROCATH-GTO & FOR
7F G/LG 94063 NEW ADHESIVES ON THE
5, 6, AND 7 FRENCH
SIZES
P890070/S3 PURE-DENT B851 GRAIN PROCESSING NEW MANUFACTURING
01/27/95 CORPORATION SPECIFICATION FOR
MUSCATINE, IA PARTICLE SIZE
52761-0349 DISTRIBUTION THROUGH
US 400 MESH 80.1%
MINIMUM FOR
ABSORBABLE DUSTING
POWDER PURE-DENT B851
P900023/S12 ABIOMED BVS 5000 ABIOMED, INC. ADDITIONAL SIZE
01/24/95 BI-VENTRICULAR ATRIAL CANNULA (I.E.,
SUPPORT SYSTEM DANVERS, MA 46 FRENCH CANNULA
01923 THAT TAPERS TO A 36
FRENCH DIAMETER) TO
BE USED WITH THE BVS
5000 BI-VENTRICULAR
SUPPORT SYSTEM
P900056/S4 ROTABLATOR HEART TECHNOLOGY, INC. APPROVAL FOR
01/24/95 ROTATIONAL ISOMEDIX, INC., EL
ANGIOPLASTY REDMOND, WA PASO, TEXAS, AS AN
SYSTEM 98052-3376 ADDITIONAL CONTRACT
STERILIZATION
FACILITY
P910019/S1 IVT CORONARY INTERVENTIONAL APPROVAL FOR
01/05/95 ATHERECTOMY TECHNOLOGIES REPLACEMENT OF THE
SYSTEM (TEC) SAN DIEGO, CA CURRENT FILLET
92123 MATERIAL, FLEXAN,
WITH CONATHANE
POLYURETHANE
P910020/S4 RELAY/DASH PACING INTERMEDICS, INC. COMMERCIAL
01/23/95 SYSTEM DISTRIBUTION OF
ANGLETON, TX UNITY C MODEL 292-06
77515 PULSE GENERATOR;MODIFY
PROGRAM MODULE SOFTWARE
INCLUDING UNITY-C;
MODIFY LABELING
P910020/S6 RELAY/DASH PACING INTERMEDICS, INC. ALTERNATIVE
01/18/95 SYSTEM - RELAY CONDUCTIVE (TYPE I,
(MODELS ANGLETON, TX GOLD-FILLED EPOXY)
294-03/293-03), 77515-4000 AND NONCONDUCTIVE
DASH (MODELS (TYPE II EPOXY)
292/03/292-03R/291 ADHESIVES ON THE
-03), STRIDE HYBRID MODULE
(MODEL 294-05)
AND DART (MODEL
292-05)
P910020/S7 RELAY/DASH PACING INTERMEDICS, INC. NEW ADDITION TO RELAY
01/17/95 SYSTEM - RELAY FAMILY OF
(MODEL 294-03R) ANGLETON, TX PACERS:TRADE NAME:
RATE RESPONSIVE, 77515 RELAY (MODEL 294-03R)
DUAL CHAMBER RATE RESPONSIVE, DUAL
IMPLANTABLE PULSE CHAMBER IMPLANTABLE
GENERATOR PULSE GENERATOR
P910023/S7 CADENCE TIERED VENTRITEX, INC. APPROVAL FOR V-110
01/17/95 THERAPY AND V-110B HEADER
DEFIBRILLATION SUNNYVALE, CA CONFIGURATIONS FOR
SYSTEM MODEL 94086-6527 THE CADENCE V-110
V-110, V-110B SERIES PULSE
GENERATORS
P910023/S9 CADENCE TIERED VENTRITEX, INC. ADDING A SHIELD TO
01/23/95 THERAPY THE MODEL AC-1000 AND
DEFIBRILLATION SUNNYVALE, CA AC-1501 PROGRAMMER
SYSTEM 94086-6527 WANDS
P910073/S5 0070 ENDOTAK C CARDIAC PACEMAKERS, APPROVAL FOR
01/25/95 LEADS INC. MANUFACTURER, DORADO
ST.PAUL, MN PUERTO RICO, TO
55112-5798 MANUFACTURE ENDOTAK C
LEAD MODELS 0070,
0072, AND 0074
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