|
Device | EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND TRANSFEMORAL ACCESSORIES |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P100041 |
Supplement Number | S041 |
Date Received | 09/26/2013 |
Decision Date | 03/28/2014 |
Withdrawal Date
|
03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THREE CHANGES PERTAINING TO THE CUTTING, TOLERANCES, AND MEASUREMENT OF THE CLOTH SKIRT ON THE EDWARDS SAPIEN¿ THV. |