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PMA Final Decisions Rendered for April 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.
P940005 ULTRAMARK 9 ADVANCED TECHNOLOGY AN ADJUNCT TO
04/11/96 HIGH DEFINITION LABORATORIES MAMMOGRAPHY AND
IMAGING (HDI) BOTHELL, WA PHYSICAL BREAST
ULTRASOUND SYSTEM 98041-3003 EXAMINATION, TO
WITH L10-5 DIFFERENTIATE BENIGN
SCANHEAD FROM MALIGNANT OR
SUSPICIOUS BREAST
LESIONS
P940042 SOLO-CARE CIBA VISION CORP. FOR CLEANING,
04/25/96 RINSING, DISINFECTING
DULUTH, GA AND STORING SOFT
30136-1518 (HYDROPHILIC) CONTACT
LENSES AND FOR
DISSOLVING ENZYME
TABLETS
N17786/S024 ALLERGAN ALLERGAN ALTERNATE CONTRACT
04/12/96 HYDROCARE OPTICAL STERILIZATION SITE,
CLEANING AND IRVINE, CA ISOTRON IRELAND LTD.,
DISINFECTING 92713-9534 OFFALY, IRELAND, AND
SOLUTION USE OF 100% ETHYLENE
OXIDE TO STERILIZE
PLASTIC BOTTLES,
TIPS, AND CAPS
N18020/S039 ALLERGAN HYDROCARE ALLERGAN ALTERNATE CONTRACT
04/12/96 PRESERVED SALINE OPTICAL STERILIZATION SITE,
SOLUTION, IRVINE, CA ISOTRON IRELAND LTD.,
SORBICARE SALINE, 92713-9534 OFFALY, IRELAND, AND
AND PRESERVED USE OF 100% ETHYLENE
SALINE OXIDE TO STERILIZE
PLASTIC BOTTLES,
TIPS, AND CAPS
N50510/S070 VITEK SYSTEMS BIOMERIEUX VITEK, ADDITION OF A
04/22/96 "GENERAL INC. LIMITATION STATEMENT
SUSCEPTIBILITY HAZELWOOD, MI REQUIRING AN ALTERNATE
CARD" 63042-2395 METHOD OF TESTING FOR
PIPERACILIN IN
SUSCEPTIBILITY
TESTING OF PSEUDOMONAS
AERUGINOSA
P790002/S016 EBI BONE HEALING ELECTRO-BIOLOGY, LABELING CHANGES
04/09/96 SYSTEM INC. TO PHYSICIAN
PARSIPPANY, NJ INSTRUCTION AND
07054-1079 PATIENT MANUALS
P790017/S052 USCI GRUNTZIG, C.R. BARD, INC. STERILIZATION SITE
04/18/96 FORCE, SPRINT, CHANGE AND A CHANGE
AND SOLO BALLOON BILLERICA, MA IN THE STERILIZATION
DILATATION 01821 CYCLE
CATHETER WITH
PRO/PEL COATING
P790024/S024 EASYCLEAN/GP, ALLERGAN ALTERNATE CONTRACT
04/12/96 LC-65, LENS OPTICAL STERILIZATION SITE
CLEAR, AND IRVINE, CA ISOTRON IRELAND LTD.,
LENS PLUS, 92715-9534 OFFALY, IRELAND, AND USE
DAILY CLEANERS OF 100% ETHYLENE OXIDE
TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P800065/S014 LENS-WET ALLERGAN ALTERNATE CONTRACT
04/12/96 LUBRICATING AND OPTICAL STERILIZATION SITE
REWETTING IRVINE, CA ISOTRON IRELAND LTD.,
SOLUTION AND 92713-9534 OFFALY, IRELAND, AND
LENS FRESH USE OF 100% ETHYLENE
LUBRICATING AND OXIDE TO STERILIZE
REWETTING DROPS PLASTIC BOTTLES, TIPS,
AND CAPS
P820018/S067 AUTIMA/AURORA TELECTRONICS PACING APPROVAL FOR
04/23/96 CARDIAC PACING SYSTEMS SUBSTRATE DESIGN
SYSTEM ENGLEWOOD, CO CHANGES
80112
P830026/S064 COSMOS FAMILY INTERMEDICS, INC. ALTERNATE
04/01/96 OF PULSE STERILIZATION PROCESS
GENERATORS ANGLETON, TX
77515
P830056/S075 POSTERIOR CHAMBER MENTOR CORP. APPROVAL FOR MODELS
04/02/96 INTRAOCULAR LENSES C420P, C540U, C445F,
(IOLS) SANTA BARBARA, CA C840U, U240F0,
93111 C540MC, U211F, AND
U241FO POSTERIOR
CHAMBER INTRAOCULAR
LENSES VIA TIER A
P840008/S053 DORNIER DORNIER MEDICAL NEW MODEL
04/11/96 LITHOTRIPTER SYSTEMS, INC. LITHOTRIPTER
MOBILE KENNESAW, GA INDICATED FOR THE
30144 FRAGMENTATION OF 5
TO 25 MILLIMETER
KIDNEY STONES SUCH AS
RENAL CALYX AND RENAL
PELVIC STONES
P840024/S061 NUCLEUS 22 COCHLEAR CORP. MODIFICATIONS TO THE
04/04/96 CHANNEL COCHLEAR AUDIO INPUT SELECTOR
IMPLANT SYSTEM ENGLEWOOD, CO (AIS), AN OPTIONAL
80112 ACCESSORY FOR THE
NUCLEUS 22 CHANNEL
COCHLEAR IMPLANT
DEVICE
P840068/S026 VISTA 4, 6, AND GUIDANT CORP. REPLACEMENT OF THE
04/16/96 T; DELTA T AND CURRENT CONNECTOR
TRS; VISTA DDD; ST. PAUL, MN TOP MATERIAL
AND VIGOR DDD 55112-5798
P850088/S033 OXYSEPT 1 ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 AND ULTRACARE STERILIZATION SITE
DISINFECTING IRVINE, CA ISOTRON IRELAND LTD.,
SOLUTIONS AND 92713-9534 OFFALY, IRELAND, AND USE
OXYSEPT 2 OF 100% ETHYLENE OXIDE
NEUTRALIZING TO STERILIZE PLASTIC
SOLUTION BOTTLES, TIPS, AND CAPS
P870007/S010 SORBIC ACID OPTOPICS LABORATORIES TRANSFER OF PROCESSING
04/22/96 PRESERVED STERILE CORP. SITE FOR 100% ETHYLENE
SALINE FOR SOFT FAIRTON, NJ OXIDE STERILIZATION
CONTACT LENSES 08320-0210 (GLEN FALLS, NY)
P870026/S006 RESOLVE/GP ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 DAILY CLEANER STERILIZATION SITE
IRVINE, CA ISOTRON IRELAND LTD.,
92715-9534 OFFALY, IRELAND AND USE
OF 100% ETHYLENE OXIDE
TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P870036/S036 VERSAFLEX MEDTRONICS REVISED LABELING
04/08/96 BUCHBINDER INTERVENTIONAL
OMNIFLEX PTCA SAN DIEGO, CA
CATHETER SYSTEM 92121-2256
MEDTRONIC 18K,
14K, EVERGREEN,
FALCON, PANTHER,
AND SPIRIT PTCA
CATHETERS
P870037/S007 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 PLUS WETTING AND STERILIZATION SITE
SOAKING SOLUTION IRVINE, CA ISOTRON IRELAND LTD.,
92715-9534 OFFALY, IRELAND AND USE OF 100% ETHYLENE OXIDE
TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P880003/S053 CORDIS CORDIS CORPORATION DEVICE MODIFICATION;
04/12/96 PERCUTANEOUS NEW TRADE NAME: CORDIS
TRANSLUMINAL MIAMI, FL THOR PTCA CATHETER
CORONARY 33102-5700
ANGIOPLASTY
(PTCA) DILATATION
CATHETERS
P880003/S055 CORDIS PTCA CORDIS CORP. DEVICE MODIFICATION;
04/23/96 DILATATION NEW TRADE NAME: CORDIS
CATHETER AND MIAMI, FL VALOR AND VALOR XL PTCA
CORDIS VALOR 33102-5700 CATHETERS
AND VALOR XL
PTCA DILATATION
CATHETERS
P880003/S056 CORDIS PTCA CORDIS CORP. ADDITIONAL BALLOON
04/23/96 DILATATION SIZES FOR THE THOR
CATHETERS AND MIAMI, FL PTCA DILATATION
CORDIS THOR PTCA 33102-5700 CATHETERS (2.75MM,
DILATATION 3.25MM, AND 3.75MM
CATHETERS DIAMETERS AND 30MM
LENGTHS)
P880031/S009 AMO VITRAX ALLERGAN MEDICAL NEW STERILIZATION
04/09/96 VISCOELASTIC OPTICS SITE (GRIFFITH MICRO
SOLUTION IRVINE, CA SCIENCE, GLEN FALLS,
92713-9534 NY) NEW STERILIZATION
PROCESS (100% ETHYLENE
OXIDE) FOR AMO VITRAX
(SODIUM HYALURONATE)
IN FINAL PACKAGING
P880031/S010 AMO VITRAX ALLERGAN MEDICAL USE OF
04/08/96 (SODIUM OPTICS "PHARMACEUTICAL
HYALURONATE) IRVINE, CA GRADE" SODIUM
92713-9534 HYALURONATE POWDER
FROM ALTERNATE SUPPLIER
P880072/S039 MODEL PA48A-OUV MEDICAL DEVELOPMENT MODELS PA48A-OUV VIA
04/08/96 ULTRAVIOLET- RESEARCH, INC. TIER A MODIFICATION
ABSORBING ST. PETERSBURG, FL
POSTERIOR CHAMBER 33716
INTRAOCULAR LENS
(IOL)
P880072/S040 MODELS GL65C-OUV MEDICAL DEVELOPMENT MODELS GL65C-OUV AND
04/17/96 AND PS50D-OUV RESEARCH, INC. PS50D-OUV VIA TIER A
ULTRAVIOLET- ST. PETERSBURG, FL MODIFICATION
ABSORBING 33716
POSTERIOR CHAMBER
INTRAOCULAR
LENSES (IOLS)
P880072/S042 POSTERIOR CHAMBER MEDICAL DEVELOPMENT APPROVAL FOR TIER A
04/24/96 INTRAOCULAR LENSES RESEARCH, INC. POSTERIOR CHAMBER
MODELS PA38E-OUV ST. PETERSBURG, FL INTRAOCULAR LENSES
AND PL52A-OUV 33716 MODELS PA38E-OUV
AND PL52A-OUV
P880098/S009 SF-P MENICON CO., LTD. LABELING CHANGES
04/03/96 (MELAFOCON A) ADDITION OF
RIGID GAS WASHINGTON, D.C. ALLERGAN, INC.'S
PERMEABLE CONTACT 20005 DESTAT 4 SYSTEM
LENS FOR EXTENDED AND ALCON
WEAR LABORATORIES, INC.'S
OPTI-SOAK SYSTEM
P890025/S009 TDX/TDXFLX ABBOTT LABORATORIES NEW PROBE CLEANING
04/01/96 CYCLOSPORINE PROCEDURE
MONOCLONAL ABBOTT PARK, IL
WHOLE BLOOD 60064-3500
P890027/S030 NUCLEUS 22 COCHLEAR CORP. MODIFICATIONS TO THE
04/04/96 CHANNEL COCHLEAR AUDIO INPUT SELECTOR
IMPLANT ENGLEWOOD, CO (AIS), AN OPTIONAL
80112 ACCESSORY FOR THE
NUCLEUS 22 CHANNEL
COCHLEAR IMPLANT
DEVICE
P900009/S002 SONIC ACCELERATED EXOGEN, INC. NEW MANUFACTURING
04/02/96 FRACTURE HEALING FACILITY WHICH IS
SYSTEM MODEL 2A PISCATAWAY, NJ OWNED AND OPERATED BY
08855 HI-TRONICS DESIGNS,
INC., AND LOCATED AT
HACKETTSTOWN, NJ
P900047/S003 WET-N-SOAK ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 REWETTING DROPS STERILIZATION SITE
IRVINE, CA ISOTRON IRELAND LTD.,
92713-9534 OFFALY, IRELAND, AND USE
OF 100% ETHYLENE OXIDE
TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P900056/S015 ROTABLATOR HEART TECHNOLOGY, ELIMINATION OF THE
04/23/96 ROTATIONAL INC. USP MOUSE SAFETY TEST
ANGIOPLASTY REDMOND, WA AS A STERILIZATION
SYSTEM 98052-3376 LOAD RELEASE
CRITERIA
P900061/S013 MODEL 7219 B/D/E MEDTRONIC, INC. APPROVAL FOR MODEL
04/15/96 JEWEL, MODEL 7202 7219 B/D/E JEWEL,
D/E JEWEL, MODEL MINNEAPOLIS, MN MODEL 7202 D/E/
7220 B/D/E JEWEL 55432-3576 JEWEL, MODEL 7220
PLUS DEVICE USED B/D/E JEWEL PLUS
WITH CPI ENDOTAK DEVICE WITH ENDOTAK
SERIES LEADS SERIES LEADS
P910023/S016 CADENCE TIERED VENTRITEX, INC. APPROVAL TO STERILIZE
04/26/96 THERAPY VENTRITEX PRODUCTS AT
DEFIBRILLATOR SUNNYVALE, CA SOREX MEDICAL, INC.,
SYSTEM 94086-6527 USING CHAMBER 9
P910073/S016 ENDOTAK SQ LEAD GUIDANT CORP. ALTERNATIVE
04/04/96 ARRAY MODEL 0048 MANUFACTURING SITE:
AND ENDOTAK SQ ST.PAUL, MN CARDIAC PACEMAKERS,
LEAD PATCH 55112-5798 INC., DEL CARIBE,
MODEL 0063 ROAD 698 LOT NO. 12,
DORADO, PUERTO RICO
00646
P910073/S018 LEAD ADAPTER GUIDANT CORP. APPROVAL FOR LEAD
04/02/96 MODELS 6024, ADAPTER MODELS 6024,
6833, AND 6931 ST.PAUL, MN 6833, 6931
55112-5798
P910073/S019 MODEL 6952 LEAD GUIDANT CORP. MODEL 6952 LEAD
04/01/96 EXTENDER EXTENDER
ST.PAUL, MN
55112-5798
P910075/S005 COMPLETE BRAND ALLERGAN OPTICAL ALTERNATE CONTRACT
04/12/96 MULTI-PURPOSE STERILIZATION SITE
SOLUTION AND IRVINE, CA ISOTRON IRELAND LTD.,
COMPLETE BRAND 92713-9534 OFFALY, IRELAND, AND USE
LUBRICATING AND OF 100% ETHYLENE OXIDE
REWETTING DROPS TO STERILIZE PLASTIC
BOTTLES, TIPS, AND CAPS
P920014/S003 TCI HEARTMATE THERMO CARDIOSYSTEMS, CHANGE IN THE DESIGN
04/12/96 IP LVAS INC. OF THE NON-BLOOD
WOBURN, MA CONTACTING TITANIUM
01888-2697 COMPONENTS USED IN
THE INFLOW AND
OUTFLOW VALVE CONDUITS
AND IN THE OUTFLOW
GRAFT CONDUIT
P920015/S009 MEDTRONIC MEDTRONIC, INC. APPROVAL FOR THE
04/08/96 MODEL 6707 MODEL 6707 ADAPTER
ADAPTER MINNEAPOLIS, MN
55432-3576
P920032/S002 MICRO-PACE MODEL PACE MEDICAL, APPROVAL FOR THE
04/26/96 4553 DUAL CHAMBER INC. PACESETTER, INC.,
DDD TEMPORARY WALTHAM, MA MODEL 3070B PRIVATE
CARDIAC PACEMAKER 02154 LABEL VERSION OF THE
PACE MEDICAL MODEL
4575
P930012/S001 PROGRESSIVE PROGRESSIVE USE OF 100% ETHYLENE
04/02/96 ANGIOPLASTY ANGIOPLASTY SYSTEMS OXIDE STERILIZATION
SYSTEMS (PAS) MENLO PARK, CA TO BE PERFORMED AT
LACROSSE PTCA 94025 MEDICAL MANUFACTURING
CORONARY CORP., ERIE, PA
DILATATION
CATHETER
P930012/S002 PROGRESSIVE PROGRESSIVE ADDITION OF 1.5MM
04/16/96 ANGIOPLASTY ANGIOPLASTY SYSTEMS DIAMETER, 20 MM
SYSTEMS (PAS) MENLO PARK, CA LENGTH BALLOON;
LACROSSE PTCA 94025-1516 ADDITION OF 2.5MM,
CORONARY 3.0MM, AND 4.0MM
DILATATION BALLOONS
CATHETER
P940034/S001 GENPROBE GEN-PROBE INC. COMPONENT, SHELF
04/23/96 AMPLIFIED LIFE, AND LABELING
MYCOBACTERIUM SAN DIEGO, CA CHANGES; NEW VENDOR
TUBERCULOSIS 92121 OF REVERSE
DIRECT (MTD) TRANSCRIPTASE
TEST
P950009/S001 AUTOPAP 300 QC NEOPATH, INC. CHANGE IN MANUAL TO
04/25/96 SYSTEM IMPROVE HOW THE
REDMOND, WA REPORT FORMS WILL
98052 LOOK, FOR CLARITY
Updated 11/15/1996
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