|
Device | HEARTMATE(R) VE LVAS |
Generic Name | Ventricular (assist) bypass |
Applicant | THORATEC CORP. 6035 STONERIDGE DR. PLEASANTON, CA 94588 |
PMA Number | P920014 |
Supplement Number | S007 |
Date Received | 07/02/1997 |
Decision Date | 09/29/1998 |
Withdrawal Date
|
10/03/2014 |
Product Code |
DSQ |
Docket Number | 99M-1520 |
Notice Date | 06/09/1999 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement approval for the HeartMate(R) VE LVAS. This device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The HeartMate(R) VE LVAS is indicated for use both inside and outside the hospital. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|