|
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 | S024 |
Date Received | 03/28/2013 |
Decision Date | 04/18/2013 |
Withdrawal Date
|
03/18/2019 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR IMPLEMENTATION OF MORE DETAILED CRIMPER MANUFACTURING INSTRUCTIONS AND ADDITIONAL QUALITY CONTROL STEPS TO ENHANCE THE SAFETY OF THE CRIMPER DEVICES. |