|
Device | THORATEC VENTRICULAR ASSIST DEVICE SYSTEM |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC LABORATORIES CORP. 2023 EIGHTH ST. BERKELEY, CA 94710 |
PMA Number | P870072 |
Supplement Number | S034 |
Date Received | 07/12/2006 |
Decision Date | 06/28/2007 |
Withdrawal Date
|
10/05/2020 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MATERIAL CHANGE IN THE TUBING THAT CONNECTS THE BODY OF THE PARACORPOREAL THORATEC VENTRICULAR ASSIST DEVICE WITH THE METAL Y-CONNECTOR THAT SPLITS THE LINE INTO SEPARATE ELECTRICAL AND PNEUMATIC CONNECTIONS. |