BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P020036 · Decision Aug 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM
    PMA Number
    P020036
    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
    August 12, 2003
    Date Received
    September 5, 2002
    Expedited Review
    N
    Docket Number
    03M-0381

    Advisory Committee Statement

    APPROVAL FOR THE S.M.A.R.T. NITINOL STENT SYSTEM AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM. THE DEVICES ARE INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ATHEROSCLEROTIC DISEASE OF THE COMMON AND/OR EXTERNAL ILIAC ARTERIES UP TO 126 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 4 TO 9 MM, AND ANGIOGRAPHIC EVIDENCE OF A PATIENT PROFUNDA OR SUPERFICIAL FEMORAL ARTERY.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac