BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intracranial Aneurysm Flow Diverter

    PMA: P170024 · Decision Jul 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Intracranial Aneurysm Flow Diverter
    Trade Name
    Surpass Streamline Flow Diverter
    PMA Number
    P170024
    Device Class
    FDA Class 3
    Product Code
    OUT
    Generic Name
    Intracranial aneurysm flow diverter
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 13, 2018
    Date Received
    July 31, 2017
    Expedited Review
    N
    Docket Number
    18M-2884

    Advisory Committee Statement

    Approval for The Surpass Streamline Flow Diverter. The Surpass Streamline Flow Diverter is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width >= 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter >= 2.5 mm and <= 5.3 mm.

    Classifications

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

    Product Code Device Name
    OUT Intracranial Aneurysm Flow Diverter