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 Prosthetic Heart Valve Ascending Aortic Prothesis |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | On-X Life Technologies, Inc. 1655 ROBERTS BLVD NW KENNESAW, GA 30144 |
PMA Number | P000037 |
Supplement Number | S059 |
Date Received | 03/01/2022 |
Decision Date | 03/24/2022 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of a new Controlled Environment Area (CEA) to perform On-X Heart Valve (HV) and Ascending Aortic Prosthesis (AAP) manufacturing steps from subassembly through sterilization and final packaging. |
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