BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Prosthesis, Mitral Valve, Percutaneously Delivered

    PMA: P250019 · Supplement: S001 · Decision Feb 19, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Prosthesis, Mitral Valve, Percutaneously Delivered
    Trade Name
    SAPIEN M3 Transcatheter Mitral Valve Replacement System
    PMA Number
    P250019
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    NPU
    Generic Name
    Prosthesis, mitral valve, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 19, 2026
    Date Received
    January 20, 2026
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPU Prosthesis, Mitral Valve, Percutaneously Delivered