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Device | SAPIEN 3 Ultra Transcatheter Heart Valve System |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S088 |
Date Received | 05/28/2019 |
Decision Date | 06/04/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the labeling of the SAPIEN 3 Ultra Transcatheter Heart Valve and Accessories regarding the option to use the eSheath as an accessory for the SAPIEN 3 Ultra procedure. |