|
Device | SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM |
Generic Name | Artificial heart |
Applicant | SYNCARDIA SYSTEMS, LLC 1992 E. SILVERLAKE RD. TUCSON, AZ 85713 |
PMA Number | P030011 |
Supplement Number | S036 |
Date Received | 10/19/2015 |
Decision Date | 12/09/2015 |
Product Code |
LOZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF TWO WARNINGS TO THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL. |