BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent Graft, Infrapopliteal, Venous Arterialization

    PMA: P220025 · Decision Sep 11, 2023
    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
    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
    September 11, 2023
    Date Received
    October 31, 2022
    Expedited Review
    N

    Advisory Committee Statement

    Approval for The LimFlow System. The device is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

    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