|
Device | SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S087 |
Date Received | 05/17/2019 |
Decision Date | 07/29/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the labeling of the SAPIEN 3 Transcatheter Heart Valve and Accessories and SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories regarding additional valve-in-valve sizing guidance for implantation inside the Edwards INSPIRIS RESILIA aortic valve model 11500A. |