BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P110035 · Decision Apr 13, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    EPIC SELF-EXPANDING NITINOL STENT SYSTEM
    PMA Number
    P110035
    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
    April 13, 2012
    Date Received
    September 13, 2011
    Expedited Review
    N
    Docket Number
    12M-0373

    Advisory Committee Statement

    APPROVAL FOR THE EPIC VASCULAR SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED FOR THE IMPROVEMENT OF LUMINAL DIAMETER IN PATIENTS WITH DE NOVO OR RESTENOTIC SYMPTOMATIC ATHEROSCLEROTIC LESIONS UP TO 120 MM IN LENGTH IN THE COMMON AND/OR EXTERNAL ILIAC ARTERIES, WITH A REFERENCE VESSEL DIAMETER BETWEEN 5 AND 11 MM.

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac