Medical Devices
1994 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for December 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
| 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 |
|
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. |
|
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 |