BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P050017 · Decision Jun 26, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    ZILVER VASCULAR STENT
    PMA Number
    P050017
    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
    June 26, 2006
    Date Received
    April 15, 2005
    Expedited Review
    N
    Docket Number
    06M-0294

    Advisory Committee Statement

    APPROVAL FOR THE ZILVER VASCULAR STENT. THIS DEVICE IS INDICATED FOR USE AS AN ADJUNCT TO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) IN THE TREATMENT OF SYMPTOMATIC VASCULAR DISEASE OF THE ILIAC ARTERIES UP TO 100 MM IN LENGTH, WITH A REFERENCE VESSEL DIAMETER OF 5 TO 9 MM. PATIENTS MUST BE SUITABLE FOR PTA AND STENT TREATMENT.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac