|
Device | SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S130 |
Date Received | 07/06/2021 |
Decision Date | 09/17/2021 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01314313
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the Instructions for Use to reflect the findings of the final Post-Approval Study (PAS) Report submitted for the SAPIEN 3 High or Greater Surgical Risk study |