BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P020036 · Supplement: S012 · Decision Dec 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    SMART NITINOL STENT SYSTEM & SMART CONTROL NITINOL STENT SYSTEM
    PMA Number
    P020036
    Supplement Number
    S012
    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 11, 2008
    Date Received
    December 3, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO INCORPORATE AN ADDITIONAL PRECAUTION INTO THE INSTRUCTIONS FOR USE TO ADDRESS THE POTENTIAL FOR STENT FRACTURES THAT MAY OCCUR WITH SELF-EXPANDING STENTS SUCH AS THE CORDIS SMART STENT SYSTEMS.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac