|
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 | P110021 |
Supplement Number | S034 |
Date Received | 01/15/2014 |
Decision Date | 02/12/2014 |
Withdrawal Date
|
03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF LABELING TO INDICATE THE CONTENTS OF DRY NATURAL RUBBER IN THE DEVICE PACKAGING. |