BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intrasaccular Flow Disruption Device

    PMA: P170032 · Supplement: S017 · Decision Sep 23, 2024
    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
    S017
    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
    September 23, 2024
    Date Received
    August 23, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    approval of the revised protocol for the post-approval study (PAS) referenced above. The revised PAS protocol has been submitted to comply with the conditions of approval outlined in our December 31, 2018, approval order for P170032

    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