|
Device | THORATEC VENTRICULAR ASSIST DEVICE(VAD) SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S033 |
Date Received | 12/27/2004 |
Decision Date | 03/22/2005 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CONTRACT STERILIZATION SITE LOCATED AT TRI-STATE HOSPITAL SUPPLY CORPORATION, YUMA, ARIZONA AND FOR A CHANGE IN THE CYTOTOXICITY TESTING PROCESS. |