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Medical Devices
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February 1995 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 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
P920051 STORZ MODULITH KARL STORZ ENDOSCOPY- USE IN NONINVASIVE 02/17/95 LITHOTRIPTER, AMERICA, INC. FRAGMENTATION OF MODEL SL20 KENNESAW, GA URINARY CALCULI IN 30144 THE KIDNEY AND UPPER URETER P930029 ATAKR RADIO MEDTRONIC CARDIORHYTHM 1)INTERRUPTION OF 02/09/95 FREQUENCY ACCESSORY CATHETER ABLATION SAN JOSE, CA ATRIOVENTRICULAR (AV) (RFCA) SYSTEM - 95134-1806 CONDUCTION PATHWAYS RF ABLATR & RF ASSOC W/TACHYCARDIA MARINR SERIES OF (TC) 2)TREATMENT OF RFCA CATHETERS AV NODAL REENTRANT TC 3)CREATION OF COMPLETE AV BLOCK
PMA Supplemental Approvals
N16-895/S83 OPTIMA BAUSCH & LOMB LABELING
02/23/95 (POLYMACON) MODIFICATIONS
VISIBILITY TINTED ROCHESTER, NY
HYDROPHILIC 04500
CONTACT LENSES
N17004 /S6 SURGICAL HOWMEDICA, INC. CHANGES MADE TO
02/24/95 SIMPLEX P PACKAGE INSERT OF THE
RADIOPAQUE BONE RUTHERFORD, NJ DEVICE
CEMENT 07070-2584
N180033/S27 ACUVUE JOHNSON & JOHNSON ALTERNATE
02/13/95 (ETAFILCON A) VISION PRODUCTS, INC. MANUFACTURING SITE
SOFT JACKSONVILLE, FL
(HYDROPHILIC) 32247
CONTACT LENSES
N50510 /S57 VITEK SYSTEMS BIOMERIEUX VITEK, INC. REMOVAL OF DISCLAIMER
02/23/95 "GENERAL FOR PSEUDOMONAS/
SUSCEPTIBILITY HAZELWOOD, MO CIPROFLOXACIN
CARD" 63042-2395
P810002/S34 ST.JUDE MEDICAL ST. JUDE MEDICAL, INC. REMOVAL OF THE
02/16/95 MECHANICAL HEART MANUFACTURING CHECK
VALVE ST. PAUL, MN SHEET REGARDING THE
55117 ORIENTATION OF THE
VALVE IN THE VALVE
HOLDER.
P810031/S18 HEALON PHARMACIA, INC. CHANGING FROM THE
02/17/95 VISCOELASTIC OPHTHALMICS RABBIT PYROGEN TEST
PRODUCTS MONROVIA, CA TO THE LIMULUS
91017-7136 AMOEBOCYTE LYSATE
(LAL) TEST FOR THE
DETECTION OF
BACTERIAL ENDOTOXIN.
P820021/S24 NEWVUES CIBA VISION NEW MODEL
02/13/95 THERAPEUTIC CORPORATION LABELING MODIFICATIONS
(VIFILCON A) SOFT DULUTH, GA
(HYDROPHILIC) 30136-1518
CONTACT LENSES
P840039/S47 ULTRAVIOLET (UV) STORZ OPHTHALMICS, USE OF A NEW LENS
02/08/95 ABSORBING AND INC. CARRIER
NON-UV ABSORBING CLEARWATER, FL
PMAA INTRAOCULAR 34619
LENSES (IOLS)
P840040/S47 MEDI-TECH BOSTON SCIENTIFIC THE DEVICE AS
02/23/95 CORONARY BALLOON CORPORATION MODIFIED WILL BE
DILATATION WATERTOWN, MA MARKETED UNDER THE
CATHETER - 02172-2414 TRADE NAME:SYNERGY II
SYNERGY II LONG CONVERTIBLE RAPID
BALLOON EXCHANGE CATHETER
DILATATION
CATHETER
P850036/S2 BAUSCH & LOMB BAUSCH & LOMB FORMULATION
02/23/95 SENSITIVE EYES ADJUSTMENT TO ENHANCE
LENS LUBRICANT ROCHESTER, NY THE STABILITY AND AN
14692-0450 ALTERNATE 3 ML SIZE
BOTTLE
P860002/S16 ULTRAVIOLET (UV) STORZ OPHTHALMICS, USE OF A NEW LENS
02/08/95 ABSORBING AND INC. CARRIER
NON-UV ABSORBING CLEARWATER, FL
PMAA INTRAOCULAR 34619
LENSES (IOLS)
P860034/S11 MODELS AC-21 ALLERGAN MEDICAL REVISED LABELING THAT
02/03/95 NON-ULTRAVIOLET- OPTICS CONTAINS 3-YEAR DATA
ABSORBING AND IRVINE, CA FOR MODELS AC-21 &
AC-21B 92718 AC-21B ANTERIOR
ULTRAVIOLET- CHAMBER INTRAOCULAR
ABSORBING LENSES (IOLS)
ANTERIOR CHAMBER
INTRAOCULAR
LENSES
P870036/S31 VERSAFLEX MEDTRONIC INTERVENTIONAL APPROVAL FOR THE
02/15/95 BUCHBINDER VASCULAR MEDTRONIC FALCON
OMNIFLEX PTCA SAN DIEGO, CA CORONARY BALLOON
CATHETER SYSTEM - 92121-2256 DILATATION CATHETER
MEDTRONIC FALCON
CORONARY BALLOON
DILATATION
CATHETER
P870073/S16 ULTRAVIOLET (UV) STORZ OPHTHALMICS, USE OF A NEW LENS
02/08/95 ABSORBING AND INC. CARRIER
NON-UV ABSORBING CLEARWATER, FL
PMMA INTRAOCULAR 34619
LENSES (IOLS)
P880079/S13 PURE EYES CIBA VISION NAME CHANGE & REVISED
02/09/95 CLEANER/RINSE CORPORATION LABELING FOR SOFTWEAR DULUTH, GA PLUS SALINE - THE
30136-1518 DEVICE WILL BE
MARKETED UNDER TRADE
NAME:PURE EYES
CLEANER/RINSE
P880090/S16 ULTRAVIOLET (UV) STORZ OPHTHALMICS, USE OF A NEW LENS
02/08/95 ABSORBING AND INC. CARRIER
NON-UV ABSORBING CLEARWATER, FL
PMMA INTRAOCULAR 34619
LENSES (IOLS)
P890003/S35 MEDTRONIC MINUET MEDTRONIC, INC. APPROVAL TO MARKET
02/15/95 PULSE GENERATOR THE REFERENCED MODELS
MODELS 7107 & MINNEAPOLIS, MN OF THE PACEMAKER AS
7108 55432-3576 THE VITATRON LEGACY D
MODELS 750 & 751
P890056/S1 MODEL PC-28LB ALLERGAN MEDICAL CHANGE STERILIZATION
02/08/95 ULTRAVIOLET-ABSOR OPTICS CYCLE TO 100%
BING POSTERIOR SANTA ANA, CA ETHYLENE OXIDE CYCLE
CHAMBER 92799-5155 WITH A NITROGEN PURGE
INTRAOCULAR LENS
P900039/S7 COLLAGRAFT BONE COLLAGEN CORPORATION PACKAGING MODIFICATIONS
02/14/95 GRAFT MATRIX
PALO ALTO, CA
94303
P900060/S3 CARBOMEDICS CARBOMEDICS, NC. APPROVAL TO UTILIZE
02/16/95 PROSTHETIC HEART NEW STEAM STERILIZER
VALVE AUSTIN, TX AND AN ENLARGED
78752-1793 CONTROLLED
ENVIRONMENT IN THE
AUSTIN MANUFACTURING
FACILITY
P910056/S3 CHIROFLEX II CHIRON VISION CHANGE IN HAPTIC PULL
02/17/95 MULTI-PIECE CORPORATION TEST
SILICONE IOLS IRVINE, CA
92718-1903
P940013/S1 PRECISION UV PILKINGTON BARNES HIND ADDITION OF LIGHT
02/09/95 (VASURFILCON) BLUE LOCATOR TINT & A
SOFT SUNNYVALE, CA CONTACT LENS
(HYDROPHILIC) 94086-5200 STABILITY EXTENSION
CONTACT LENSES PROTOCOL & AN
FOR EXTENDED WEAR ALTERNATE
(CLEAR & TINTED) MANUFACTURING SITE
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