BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Occluder, Internal Vessel, Temporary

    PMA: P110003 · Decision Sep 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Occluder, Internal Vessel, Temporary
    Trade Name
    LEGOO
    PMA Number
    P110003
    Device Class
    FDA Class 3
    Product Code
    OBC
    Generic Name
    Occluder, internal vessel, temporary
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    September 28, 2011
    Date Received
    January 31, 2011
    Expedited Review
    N
    Docket Number
    11M-0746

    Advisory Committee Statement

    APPROVAL FOR THE LEGOO. THIS DEVICE IS INDICATED FOR TEMPORARY ENDOVASCULAR OCCLUSION OF BLOOD VESSELS BELOW THE NECK UP TO 4 MM IN DIAMETER.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OBC Occluder, Internal Vessel, Temporary