BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P110028 · Decision Feb 22, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
    PMA Number
    P110028
    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
    February 22, 2012
    Date Received
    July 25, 2011
    Expedited Review
    N
    Docket Number
    12M-0181

    Advisory Committee Statement

    APPROVAL FOR THE ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM. THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC ATHEROSCLEROTIC LESIONS IN THE NATIVE COMMON ILIAC ARTERY AND NATIVE EXTERNAL ILIAC ARTERY WITH REFERENCE VESSEL DIAMETERS BETWEEN 4.3 MM AND 9.1 MM AND LESIONS LENGTHS UP TO 90 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