FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
PMA Final Decisions Rendered for February 1995 |
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.
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
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
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH