BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac Vein

    PMA: P180037 · Decision Mar 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Stent, Iliac Vein
    Trade Name
    Venovo Venous Stent System
    PMA Number
    P180037
    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
    March 13, 2019
    Date Received
    September 14, 2018
    Expedited Review
    N
    Docket Number
    19M-1214

    Advisory Committee Statement

    Approval for the Venovo Venous Stent System. The device is indicated for the treatment of symptomatic iliofemoral 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