BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent, Iliac

    PMA: P940019 · Decision May 28, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Stent, Iliac
    Trade Name
    WALLSTENT(R) ILIAC ENDOPROSTHESIS
    PMA Number
    P940019
    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
    May 28, 1996
    Date Received
    June 9, 1994
    Expedited Review
    N
    Docket Number
    97M-0054

    Advisory Committee Statement

    APPROVAL FOR THE 6 MM THROUGH 10 MM DIAMETER WALLSTENT ILIAC ENDOPROSTHESIS

    Classifications

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

    Product Code Device Name
    NIO Stent, Iliac