|
Device | HEARTMATE XVE LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S019 |
Date Received | 02/07/2003 |
Decision Date | 06/29/2004 |
Withdrawal Date
|
10/03/2014 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL OF THE POST APPROVAL STUDY FOR THE DEVICE. |