|
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 | S053 |
Date Received | 04/22/2013 |
Decision Date | 06/21/2013 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE IN SECONDARY PACKAGING OF THE VAD SEALED ARTERIAL CANNULA AND THE INTERMEDIATE BULK SHIPMENT CONFIGURATION. |