BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac Vein

    PMA: P200026 · Supplement: S003 · Decision Nov 5, 2021
    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
    Supplement Number
    S003
    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 5, 2021
    Date Received
    October 13, 2021
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the Instructions for Use (IFU) to provide clarifications and new information regarding vessel measurement and stent selection.

    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