|
Device | Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve |
Generic Name | Pulmonary valve prosthesis percutaneously delivered |
Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
PMA Number | P200015 |
Supplement Number | S015 |
Date Received | 10/19/2021 |
Decision Date | 11/18/2021 |
Product Code |
NPV |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of new cleanroom. |