BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P140030 · Decision Dec 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    ASTRON PERIPHERAL SELF-EXPANDING NITINOL STENT SYSTEM
    PMA Number
    P140030
    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
    December 17, 2015
    Date Received
    December 18, 2014
    Expedited Review
    N
    Docket Number
    15M-4947

    Advisory Committee Statement

    APPROVAL FOR THE ASTRON PERIPHERAL SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETERIN PATIENTS WITH ILIAC ATHEROSCLEROTIC LESIONS IN VESSEL REFERENCE DIAMETERS BETWEEN 4.3MM AND9.5MM AND LESION LENGTHS UP TO 105MM.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac