BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Iliac Covered Stent, Arterial

    PMA: P120003 · Supplement: S006 · Decision Jul 7, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Iliac Covered Stent, Arterial
    Trade Name
    iCast Covered Stent System
    PMA Number
    P120003
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    PRL
    Generic Name
    Iliac covered stent, arterial
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 7, 2025
    Date Received
    August 1, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    approval for a labeling update to reflect the use of the iCast Covered Stent System as a bridging stent between a branch vessel and an endovascular graft for treatment of patients with aneurysmal disease, limited to endovascular grafts that are approved for use with iCast

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PRL Iliac Covered Stent, Arterial