BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P110043 · Decision Jul 31, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEM
    PMA Number
    P110043
    Device Class
    FDA Class 3
    Product Code
    NIO
    Generic Name
    STENT, ILIAC
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 31, 2012
    Date Received
    December 30, 2011
    Expedited Review
    N
    Docket Number
    12M-0833

    Advisory Committee Statement

    APPROVAL FOR THE OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM. THIS DEVICE IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC ILIAC ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS OF >= 5.0 MM AND <= 11.0 MM AND LESION LENGTHS UP TO 50 MM.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac