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. |
|
Device | On-X Ascending Aortic Prosthesis |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | On-X Life Technologies, Inc. 1655 ROBERTS BLVD NW KENNESAW, GA 30144 |
PMA Number | P000037 |
Supplement Number | S056 |
Date Received | 04/15/2020 |
Decision Date | 10/13/2021 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
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 several changes to the On-X Ascending Aortic Prosthesis including changes to the yarn and gelatin component manufacturing and changes to device labeling. |
|
|