Atlas FDA

SAPIEN M3 Transcatheter Mitral Valve Replacement System

FDA premarket approval P250019 · decided 2025-12-22

Approval details

PMA number
P250019
Trade name
SAPIEN M3 Transcatheter Mitral Valve Replacement System
Generic name
Prosthesis, mitral valve, percutaneously delivered
Applicant
Edwards Lifesciences, LLC
Date received
2025-06-25
Decision date
2025-12-22
Days to decision
180 days
Decision code
APPR
Product code
NPU
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for the SAPIEN M3 transcatheter mitral valve replacement system. This device is indicated for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation (MR) in patients who are deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER) therapy by a multidisciplinary heart team. It is also indicated for the treatment of symptomatic mitral valve dysfunction (moderate-to-severe or severe MR, severe mitral stenosis (MS), or moderate MR with moderate MS) a

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