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Device | SAPIEN 3 Transcatheter Heart Valve and Accessories |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S090 |
Date Received | 07/16/2019 |
Decision Date | 08/15/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a revision to the Instructions for Use (IFU) for the Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System with the Edwards SAPIEN 3 Ultra Delivery System to add a warning related to balloon burst during the valve deployment process. |