|
Device | Sapien XT Transcatheter Heart Valve and Accessories |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P130009 |
Supplement Number | S100 |
Date Received | 08/30/2019 |
Decision Date | 09/17/2019 |
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 the introduction of 100% visual inspection of the Sapien XT introducer sheath. |