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

    Prosthesis, Mitral Valve, Percutaneously Delivered

    PMA: P250019 · Supplement: S002 · Decision Mar 11, 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
    Edwards SAPIEN M3 Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm, 29mm)
    PMA Number
    P250019
    Supplement Number
    S002
    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
    March 11, 2026
    Date Received
    February 10, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    alternate suppliers of solutions used in the manufacturing process of transcatheter and surgical heart valves

    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