|
Device | Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent |
Generic Name | Pulmonary valve prosthesis percutaneously delivered |
Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
PMA Number | P200015 |
Supplement Number | S021 |
Date Received | 05/25/2022 |
Decision Date | 06/23/2022 |
Product Code |
NPV |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT05378386
|
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 revised protocol for the post-approval study 2: Alterra New Enrollment Study. |