|
Device | SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S145 |
Date Received | 08/25/2022 |
Decision Date | 09/23/2022 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the post-approval study (PAS) protocol. |