BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intrasaccular Flow Disruption Device

    PMA: P170032 · Supplement: S007 · Decision Jul 16, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Intrasaccular Flow Disruption Device
    Trade Name
    Woven EndoBridge Aneurysm Embolization (WEB) System
    PMA Number
    P170032
    Supplement Number
    S007
    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
    July 16, 2021
    Date Received
    April 23, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the change in antioxidants used in the dispenser hoop of packaging of the Flow Re-Direction Endoluminal Device (FRED) System, Woven EndoBridge (WEB) Aneurysm Embolization System and Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. devices.

    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