BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac Vein

    PMA: P230021 · Decision Dec 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Stent, Iliac Vein
    Trade Name
    Duo Venous Stent System
    PMA Number
    P230021
    Device Class
    FDA Class 3
    Product Code
    QAN
    Generic Name
    Stent, iliac vein
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 26, 2023
    Date Received
    July 3, 2023
    Expedited Review
    N
    Docket Number
    24M-0045

    Advisory Committee Statement

    The Duo Venous Stent System is intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction. The Duo Hybrid is intended to be used in the iliac vein at the confluence of the inferior vena cava only. The Duo Extend is intended for use in the common iliac and common femoral veins.

    Classifications

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

    Product Code Device Name
    QAN Stent, Iliac Vein