BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac Vein

    PMA: P230021 · Supplement: S002 · Decision Nov 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Stent, Iliac Vein
    Trade Name
    Duo Venous Stent System
    PMA Number
    P230021
    Supplement Number
    S002
    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
    November 18, 2025
    Date Received
    July 31, 2025
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a design ownership and legal manufacturer located at Philips Image Guided Therapy Corporation (Philips), 5905 Nathan Lane North, Plymouth, MN 55442 and 9965 Federal Drive, Colorado Springs, CO 80921 USA

    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