|
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 | S107 |
Date Received | 01/27/2020 |
Decision Date | 07/22/2020 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02675114
|
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 modifying the labeling to remove the precaution regarding patients with a congenital bicuspid aortic valve. |
Post-Approval Study | Show Report Schedule and Study Progress |