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 | ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | On-X Life Technologies, Inc. 1655 ROBERTS BLVD NW KENNESAW, GA 30144 |
PMA Number | P000037 |
Supplement Number | S048 |
Date Received | 12/09/2016 |
Decision Date | 02/07/2017 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for multiple changes, including clinical changes to the current protocol for the post-approval study (PAS) protocol. |
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