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Premarket Approval Listing for 1994

 related information

Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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
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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