BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac Vein

    PMA: P200026 · Decision Oct 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Stent, Iliac Vein
    Trade Name
    Abre Venous Self-expanding Stent System
    PMA Number
    P200026
    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
    October 21, 2020
    Date Received
    April 27, 2020
    Expedited Review
    N
    Docket Number
    20M-2118

    Advisory Committee Statement

    Approval for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

    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