|
Device | Edwards Commander Delivery System |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S146 |
Date Received | 09/09/2022 |
Decision Date | 04/04/2023 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of a new Edwards manufacturing facility located in Limerick, Ireland as an alternate manufacturing site for the Edwards Commander Delivery system sizes 23mm and 26mm. |