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. |
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Device | SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART |
Generic Name | Artificial heart |
Applicant | SYNCARDIA SYSTEMS, LLC 1992 E. SILVERLAKE RD. TUCSON, AZ 85713 |
PMA Number | P030011 |
Supplement Number | S027 |
Date Received | 08/04/2014 |
Decision Date | 09/12/2014 |
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 |
Approval Order Statement APPROVAL FOR SEVERAL DESIGN CHANGES TO THE SYNCARDIA COMPANION 2DRIVER PRESSURE SENSOR PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND THE ADDITION OF AN ALTERNATE SUPPLIER FOR THE PRESSURE SENSOR PCBA. |
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