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

    Intrasaccular Flow Disruption Device

    PMA: P170032 · Supplement: S021 · Decision May 1, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Intrasaccular Flow Disruption Device
    Trade Name
    Woven EndoBridge (WEB) Aneurysm Embolization System
    PMA Number
    P170032
    Supplement Number
    S021
    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 1, 2026
    Date Received
    April 2, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for an alternate manufacturer of the WEB delivery system subassembly at MicroVention Inc.’s Costa Rica facility

    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