|
Device | SYNCARDIA TEMPORARY CARDIOWEST TOTAL ARTIFICIAL HEART (TAH-T) |
Generic Name | Artificial heart |
Applicant | SYNCARDIA SYSTEMS, LLC 1992 E. SILVERLAKE RD. TUCSON, AZ 85713 |
PMA Number | P030011 |
Supplement Number | S001 |
Date Received | 05/10/2005 |
Decision Date | 10/26/2005 |
Product Code |
LOZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE. |