BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intrasaccular Flow Disruption Device

    PMA: P170032 · Decision Dec 31, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Intrasaccular Flow Disruption Device
    Trade Name
    Woven EndoBridge (WEB) Aneurysm Embolization System
    PMA Number
    P170032
    Device Class
    FDA Class 3
    Product Code
    OPR
    Generic Name
    Intrasaccular Flow Disruption Device
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 31, 2018
    Date Received
    September 28, 2017
    Expedited Review
    N
    Docket Number
    19M-0027

    Advisory Committee Statement

    Approval for use in adults to embolize saccular intracranial wide neck bifurcation aneurysms located in the anterior (middle cerebral artery (MCA) bifurcation, internal carotid artery (ICA) terminus, anterior communicating artery (AComm) complex) and posterior (basilar apex) circulations, ranging in size from 3 mm to 10 mm in dome diameter, where the neck size is 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2.

    Classifications

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

    Product Code Device Name
    OPR Intrasaccular Flow Disruption Device