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 | SJM Masters Series Mechanical Heart Valve, 15mm HP |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P810002 |
Supplement Number | S101 |
Date Received | 06/21/2017 |
Decision Date | 03/06/2018 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02097420
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of the 15-mm HP valve, models 15 AHPJ-505 and 15 MHPJ-505, to the Masters Series Mechanical Heart Valve with Hemodynamic Performance Sewing Cuff product line. |
Post-Approval Study | Show Report Schedule and Study Progress |
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