|
Device | SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S131 |
Date Received | 07/20/2021 |
Decision Date | 08/12/2021 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling update to add a precaution regarding limitations of deriving gradient estimates from Doppler echocardiography. |