|
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 | S049 |
Date Received | 02/27/2014 |
Decision Date | 03/27/2014 |
Withdrawal Date
|
03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00530894
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement ALTERNATE SUPPLIER OF HYDROGEN PEROXIDE. |
Post-Approval Study | Show Report Schedule and Study Progress |