|
Device | Edwards SAPIEN 3 Transcatheter Heart Valve |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P140031 |
Supplement Number | S067 |
Date Received | 05/29/2018 |
Decision Date | 07/23/2018 |
Product Code |
NPT |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for various modifications to the protocols for the "ODE Lead PMA PAS - Continued follow-up of the premarket cohort" of the PIIS3HR and PIIS3i trials. |