BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent Graft, Bypass, Superficial Femoral Artery

    PMA: P220021 · Supplement: S007 · Decision Jan 22, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Stent Graft, Bypass, Superficial Femoral Artery
    Trade Name
    DETOUR System
    PMA Number
    P220021
    Supplement Number
    S007
    Device Class
    FDA Class 3
    Product Code
    QWM
    Generic Name
    Stent graft, bypass, superficial femoral artery
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 22, 2026
    Date Received
    September 30, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changes to the stent graft lot release testing and criteria

    Classifications

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

    Product Code Device Name
    QWM Stent Graft, Bypass, Superficial Femoral Artery