|
Device | HEARTMATE IP AND VE LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S010 |
Date Received | 12/01/1999 |
Decision Date | 12/10/1999 |
Withdrawal Date
|
10/03/2014 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval to introduce self-locking screw rings to attach the pump elbows to the two valved conduits and the outflow valved conduit to the outflow graft. |