|
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 | S054 |
Date Received | 04/07/2017 |
Decision Date | 05/12/2017 |
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 of supplier for the Freedom Driver main Printed Circuit Board Assembly (PCBA). |