BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Iliac

    PMA: P110011 · Decision Oct 26, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM
    PMA Number
    P110011
    Device Class
    FDA Class 3
    Product Code
    NIO
    Generic Name
    STENT, ILIAC
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    October 26, 2011
    Date Received
    April 1, 2011
    Expedited Review
    N
    Docket Number
    11M-0791

    Advisory Committee Statement

    APPROVAL FOR THE ASSURANT COBALT ILIAC BALLOON-EXPANDABLE STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING ILIAC LUMINAL DIAMETER IN PATIENTS WITH DE NOVO AND RESTENOTIC LESIONS IN THE COMMON AND EXTERNAL ILIAC ARTERIES, WITH REFERENCE VESSEL DIAMETERS BETWEEN 6 MM AND 10 MM AND LESION LENGTHS UP TO 61 MM. THE STENT IS INTENDED AS A PERMANENT IMPLANT.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac