# P250019: SAPIEN M3 Transcatheter Mitral Valve Replacement System

- Pathway: PMA
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 22, 2025 after 180 days
- Product code: NPU (Prosthesis, Mitral Valve, Percutaneously Delivered)
- Device class: 3
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P250019
Methodology: https://510kreport.com/methodology