BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac Vein

    PMA: P200023 · Supplement: S007 · Decision Feb 8, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15

    Basic Information

    Device Name
    Stent, Iliac Vein
    Trade Name
    Zilver Vena Venous Self-Expanding Stent
    PMA Number
    P200023
    Supplement Number
    S007
    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
    February 8, 2024
    Date Received
    October 27, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changes to the materials used in your delivery system sheath assembly

    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