BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac Vein

    PMA: P200026 · Supplement: S015 · Decision Dec 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent, Iliac Vein
    Trade Name
    Abre Venous Self-expanding Stent System
    PMA Number
    P200026
    Supplement Number
    S015
    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 12, 2025
    Date Received
    November 25, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the introduction of additional criteria to your austenite finish temperature for the 10, 12 and 14 mm stent diameter

    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