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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 | S015 |
Date Received | 06/08/2012 |
Decision Date | 08/10/2012 |
Product Code |
LOZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN THE PRESSURE LIMIT RANGE FOR THE EXTERNAL AIR PRESSURE REGULATOR OF THE DEVICE. |
Post-Approval Study | Show Report Schedule and Study Progress |