PMA P250019S001

Device: SAPIEN M3 Transcatheter Mitral Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P250019
Supplement: S001
Product code: NPU
Decision date: 2026-02-19
Classification: Cardiovascular
Generic name: Prosthesis, mitral valve, percutaneously delivered
Approval order statement: Approval of the protocols for the post-approval studies, "Continued Follow-up of ENCIRCLE Premarket Cohort" and "Registry-Based Real-World Use Surveillance", submitted to comply with the conditions of approval outlined in the approval order for P250019.

Current openFDA PMA Record#

Device: SAPIEN M3 Transcatheter Mitral Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P250019
Supplement: S001
Product code: NPU
Generic name: Prosthesis, mitral valve, percutaneously delivered
Decision date: 2026-02-19
Decision code: APPR
Date received: 2026-01-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocols for the post-approval studies, "Continued Follow-up of ENCIRCLE Premarket Cohort" and "Registry-Based Real-World Use Surveillance", submitted to comply with the conditions of approval outlined in the approval order for P250019.