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

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P140031 · Supplement: S193 · Decision Oct 2, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29
    PMA Number
    P140031
    Supplement Number
    S193
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic 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
    NPT Aortic Valve, Prosthesis, Percutaneously Delivered