|
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 | S055 |
Date Received | 07/02/2013 |
Decision Date | 12/10/2013 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF THE ADDITION OF A PVAD ISOLATION MODULE (PIM) FOR USE WITH THE PVAD AND THE DUAL DRIVE CONSOLE (DDC). |