|
Device | THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S036 |
Date Received | 04/16/2007 |
Decision Date | 07/27/2007 |
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 A CHANGE IN THE DESIGN OF THE THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE SYSTEM?S PNEUMATIC LINE. |