BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Aortic Valve, Prosthesis, Percutaneously Delivered

    PMA: P140031 · Supplement: S143 · Decision Mar 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Aortic Valve, Prosthesis, Percutaneously Delivered
    Trade Name
    Edwards Commander Delivery System
    PMA Number
    P140031
    Supplement Number
    S143
    Device Class
    FDA Class 3
    Product Code
    NPT
    Generic Name
    Aortic valve, prosthesis, percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 9, 2023
    Date Received
    August 9, 2022
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the following manufacturing sites to conduct ethylene oxide sterilization of the Commander Delivery System (Models 9600LDS23, 9750CM23, 9600LDS26, and 9750CM26): (1) Sterigenics, Belgium, located at Zoning Industriel de Petit-Rechain Avenue Andre Ernst 21 Verviers Liege, B-4800 BE, and (2) STERIS Tullamore, located at IDA Business and Technology Park, Tullamore Offaly, IE R35 X865

    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