BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent Graft, Bypass, Superficial Femoral Artery

    PMA: P220021 · Supplement: S001 · Decision Aug 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stent Graft, Bypass, Superficial Femoral Artery
    Trade Name
    DETOUR System
    PMA Number
    P220021
    Supplement Number
    S001
    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
    August 9, 2023
    Date Received
    July 10, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the protocol for the post-approval study (PAS) protocol.

    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