|
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 | S047 |
Date Received | 01/15/2014 |
Decision Date | 02/12/2014 |
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. |