|
Device | TCI HEARTMATE(R) 1000A IP LVAD |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S001 |
Date Received | 12/19/1994 |
Decision Date | 12/16/1999 |
Withdrawal Date
|
10/03/2014 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to use Cardioflex(R) instead of Biomer for manufacturing the diaphragms for the device. The device is indicated for use as a bridge to transplantation in cardiac trnasplant candidates at risk of imminent death from nonreversible left ventricular failure. |