BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent Graft, Infrapopliteal, Venous Arterialization

    PMA: P220025 · Supplement: S002 · Decision Jul 11, 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, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft
    PMA Number
    P220025
    Supplement Number
    S002
    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
    July 11, 2024
    Date Received
    March 18, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the thumbwheel delivery system and contract manufacturer, Confluent Medical (Alajuela, Costa Rica), and new contract sterilizer, Steris AST (Alajuela, Costa Rica)

    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