|
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 | S037 |
Date Received | 07/18/2013 |
Decision Date | 01/31/2014 |
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 A CHANGE IN MATERIAL TO THE MANDRELS USED AS MANUFACTURING AIDS FOR THE DELIVERY SYSTEM. |