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

    Stent Graft, Infrapopliteal, Venous Arterialization

    PMA: P220025 · Supplement: S008 · Decision Jan 7, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent Graft, Infrapopliteal, Venous Arterialization
    Trade Name
    LimFlow System
    PMA Number
    P220025
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    QWN
    Generic Name
    Stent graft, infrapopliteal, venous arterialization
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 7, 2026
    Date Received
    December 12, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a manufacturing process change for the soft tip bond

    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