Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | 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 | S021 |
Date Received | 01/10/2013 |
Decision Date | 02/08/2013 |
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 CHANGES AFFECTING THE SUPPLIERS OF THE RAW MATERIALS FOR POLYPROPYLENE MONOFILAMENT THREAD, POLYETHYLENE TEREPHTHALATE WOVEN RIBBON, AND VESTAMID RESIN. |
|
|