BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Intrasaccular Flow Disruption Device

    PMA: P170032 · Supplement: S013 · Decision May 22, 2023
    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
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    OPR
    Generic Name
    Intrasaccular Flow Disruption Device
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 22, 2023
    Date Received
    April 24, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of an alternate supplier of components used for the printed circuit board assembly of the Woven EndoBridge (WEB) Detachment Controller (WDC-2) of the WEB Aneurysm Embolization System.

    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