BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Prosthesis, Mitral Valve, Percutaneously Delivered

    PMA: P250019 · Supplement: S003 · Decision Apr 16, 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
    S003
    Device Class
    FDA Class 3
    Product Code
    NPU
    Generic Name
    Prosthesis, mitral valve, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 16, 2026
    Date Received
    March 18, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    an alternative method to process devices prior to RESILIA treatment, and cleanroom modifications to accommodate this alternative processing method

    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