|
Device | EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P110021 |
Supplement Number | S035 |
Date Received | 02/07/2014 |
Decision Date | 03/10/2014 |
Withdrawal Date
|
03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO THE MANUFACTURING PROCESS OF THE CRIMPER COMPONENT FOR THE 26 MM DEVICE SIZE. |