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 | SAPIEN TRANSCATHETER HEART VALVE (THV) |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P110021 |
Supplement Number | S045 |
Date Received | 09/22/2014 |
Decision Date | 10/20/2014 |
Withdrawal Date
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03/18/2019 |
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 IMPLEMENTATION OF AN ADDITIONAL OD INSPECTION TO THE SAPIEN® AND SAPIEN XT TRANSCATHETER HEART VALVES, MODELS 9000TFX AND 9300TFX. |
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