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 | Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S121 |
Date Received | 01/23/2024 |
Decision Date | 04/03/2024 |
Product Code |
LWQ |
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 for implementing rebranding of the SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, and SJM Masters Valved Graft with Hemashield graft technology. |
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