|
Device | EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES RETROFLEX 3 DELIVERY SYSTEM |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P110021 |
Supplement Number | S014 |
Date Received | 05/16/2013 |
Decision Date | 06/10/2013 |
Withdrawal Date
|
03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE STENT LENGTH SPECIFICATION AND CHANGES TO THE PRODUCT LABELING WHICH INCLUDED A CHANGE TO THE LABELED LENGTH OF THE STENT AND MINOR EDITORIAL MODIFICATIONS. |