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Premarket Approval Listing for 1994 |
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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.
APPLICATION NUMBER/ DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
---|---|---|
P890056
5/26/94 |
Model PC-28LB Posterior Chamber Intraocular Lens | Allergan Medical Optics |
P900007
9/30/94 |
Cook Chorionic Villus Sampling Set | Cook OB/GYN |
P900009
10/5/94 |
Sonic Accelerated Fracture Healing System Model 2A | Exogen, Inc |
P900029
1/10/94 |
NDS Lens Maintenance System | Ciba Vision Corp. |
P900038
4/20/94 |
Parastep-I
Electrical Stimulation for Paraplegics |
Sigmedics, Inc. |
P900042
1/18/94 |
Aware Test System
Drugs of Abuse Test System |
Laboratory Specialists of America, Inc. |
P900043
8/2/94 |
Palmaz-Schatz Balloon Expandable Stent | Cordis Corporation |
P900059
8/5/94 |
Albunex® Echocardiography Contrast Microspheres | Mallinckrodt Medical, Inc. |
P910031
9/30/94 |
Oracle Coronary Balloon Dilatation Catheter | Cardiovascular Dynamics, Inc. |
P910054
6/28/94 |
INOUE Balloon Catheter | Toray Industries (America), Inc. |
P910061
9/2/94 |
Model LI30U Soflex UV-Absorbable Intraocular Lens | Chiron Vision, Corp. |
P910066
3/4/94 |
Orthologic 1000 bone Growth Stimulator | Orthologic Corporation |
P910071
11/4/94 |
Adatomed Silicone Oil OP5000 | Chiron Vision Corporation |
P910075
6/1/94 |
Wesley-Jessen® WJD-1 Multi-Purpose Solution | Allergan Optical |
P910077
6/17/94 |
Ventak® PRX Model 1700, 1705 Pulse Generator | Guidant Corporation |
P920008
3/7/94 |
UCL-55, UCL-55 Toric (Ocufilcon C) Soft Contact Lens | United Contact Lens, Inc. |
P920014
9/30/94 |
TCI Heartmate® 1000A IP LVAD | Thermo Cardiosystems, Inc. |
P920021
6/20/94 |
OPUS® CEA | Behring Diagnostics, Inc. |
P920027
10/21/94 |
Albumin Coated Debakey® Vascular® Vascular-II | C.R. Bard, Inc.
Bard Vascular Systems Div. |
P920030
9/2/94 |
Ciba Corning ACS PSA Immunoassay | Ciba Corning Diagnostics, Corporation |
P920032
3/10/94 |
Model 4553 Dual Chamber DDD Temporary Cardiac Pacemaker | Pace Medical |
P920045
1/24/94 |
OP-3 RGP Contact Lens | Stellar Contact Lens, Inc. |
P920047
10/28/94 |
EP Technologies Cardiac Ablation System | EP Technologies, Inc. |
P930005
2/28/94 |
Steridyne Sterile Preserved Saline Solution | K.C. Pharmaceuticals, Inc. |
P930014
12/22/94 |
Acrysof® UV Absorbing Intraocular Lenses | Alcon Laboratories |
P930017
8/23/94 |
Ciba Corning ACS CEA Assay | Ciba Corning Diagnostics, Corporation |
P930024
6/2/94 |
Grieshaber Scleral Buckling Balloon Catheter | Grieshaber & Co. |
P940009
9/29/94 |
PTCA Catheter | Scimed Life Systems, Inc. |
P940013
9/30/94 |
Precision UV (Vasurfilcon) | Wesley-Jessen |
Updated 8/1/1997
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