BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent Graft, Bypass, Superficial Femoral Artery

    PMA: P220021 · Supplement: S005 · Decision Sep 18, 2025
    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
    S005
    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
    September 18, 2025
    Date Received
    March 10, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Endologix, LLC at 3910 Brickway Blvd., Santa Rosa, CA 95403 for manufacturing the ENDOCROSS Device and associated manufacturing changes and for an alternate contract sterilizer for the ENDOCROSS Device located at Steris Isomedix Services at 43425 Business Park Drive, Temecula, CA 92590

    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