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Device | Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S141 |
Date Received | 05/02/2022 |
Decision Date | 07/28/2022 |
Product Code |
NPT |
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 the Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve. |
Post-Approval Study | Show Report Schedule and Study Progress |