|
Device | SAPIEN THV WITH RETROFLEX FOR INOPERABLE PATIENTS AND WITH RETROFLEX OR ASCENDRA FOR HIGH RISK OPERABLE |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P100041 |
Supplement Number | S056 |
Date Received | 07/17/2014 |
Decision Date | 08/28/2014 |
Withdrawal Date
|
03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |