|
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 | S050 |
Date Received | 03/03/2017 |
Decision Date | 12/06/2017 |
Product Code |
LOZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the sub-supplier of the cannula velour component of the TAH-t. |