BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intrasaccular Flow Disruption Device

    PMA: P170032 · Supplement: S012 · Decision Feb 5, 2024
    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
    S012
    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
    February 5, 2024
    Date Received
    March 6, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    approval for labeling changes to incorporate the completed results (through 5 years postoperative) from the post-approval study (PAS) titled “WEB-IT Study”.

    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