|
Device | THORATEC VENTRICULAR ASSIST DEVICE (VAD) |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S056 |
Date Received | 07/05/2013 |
Decision Date | 07/16/2013 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement ADDITION OF A NEW DIRECTIONAL FLOW VALVE (DFV) LEAK TESTER. |