BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P020036 · Supplement: S002 · Decision Mar 19, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    SMART CONTROL NITINOL STENT SYSTEM
    PMA Number
    P020036
    Supplement Number
    S002
    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
    March 19, 2004
    Date Received
    November 24, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGE TO THE DELIVER SYSTEM OF THE S.M.A.R.T. CONTROL NITINOL STENT SYSTEM: 1) THE WIRE LUMEN OF THE DELIVERY SYSTEM WILL BE FABRICATED FROM DIFFERENT MATERIALS. 2) THE NEW WIRE LUMEN INNER DIAMETER SPECIFICATION HAS BEEN INCREASED. 3) THE PROXIMAL LAND SECTION OF THE DISTAL TIP HAS BEEN INCREASED. 4) THE INNER DIAMETER SPECIFICATION OF THE DISTAL TIP HAS BEEN INCREASE.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac