BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent Graft, Infrapopliteal, Venous Arterialization

    PMA: P220025 · Supplement: S004 · Decision Dec 20, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stent Graft, Infrapopliteal, Venous Arterialization
    Trade Name
    LimFlow System
    PMA Number
    P220025
    Supplement Number
    S004
    Device Class
    FDA Class 3
    Product Code
    QWN
    Generic Name
    Stent graft, infrapopliteal, venous arterialization
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 2024
    Date Received
    July 23, 2024
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the use of an additional sterilization chamber for ethylene oxide sterilization at the current contract sterilization facility.

    Classifications

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

    Product Code Device Name
    QWN Stent Graft, Infrapopliteal, Venous Arterialization