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

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P200015 · Supplement: S070 · Decision Oct 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Pulmonary Valve Prosthesis Percutaneously Delivered
    Trade Name
    Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29
    PMA Number
    P200015
    Supplement Number
    S070
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 2, 2025
    Date Received
    September 3, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the addition of a new Ethylene Oxide (EO) Sterilization Line at the existing and approved EO sterilization facility

    Classifications

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

    Product Code Device Name
    NPV Pulmonary Valve Prosthesis Percutaneously Delivered