Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S164 |
Date Received | 08/30/2023 |
Decision Date | 09/12/2023 |
Product Code |
NPT |
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 Implement the cleaning process for the PVL (paravalvular leak) skirt cloth component using the 70% lsopropyl Alcohol at the Edwards Singapore facility. |
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