Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
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 | S089 |
Date Received | 01/23/2024 |
Decision Date | 03/04/2024 |
Product Code |
LOZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a minor change to the Freedom Driver onboard battery service life evaluation criteria to extend the service life of the batteries. |
|
|