BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Stent, Iliac

    PMA: P090006 · Decision Mar 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    COMPLETE SE VASCULAR STENT SYSTEM
    PMA Number
    P090006
    Device Class
    FDA Class 3
    Product Code
    NIO
    Generic Name
    STENT, ILIAC
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 17, 2010
    Date Received
    April 15, 2009
    Expedited Review
    N
    Docket Number
    10M-0158

    Advisory Committee Statement

    APPROVAL FOR THE COMPLETE SE VASCULAR STENT SYSTEM (20-100MM LENGTHS). THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER IN PATIENTS WITH ILIAC STENOSIS IN PREVIOUSLY UNSTENTED LESIONS WITH VESSEL REFERENCE DIAMETERS BETWEEN 4.5MM AND 9.5MM AND LESION LENGTHS UP TO 90MM.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac