|
Device | EDWARDS SAPIEN TRANSCATHETER HEART VALVE |
Generic Name | aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. one edwards way irvine, CA 92614 |
PMA Number | P100041 |
Supplement Number | S002 |
Date Received | 12/05/2011 |
Decision Date | 04/06/2012 |
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. |