BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Occluder, Internal Vessel, Temporary

    PMA: P110003 · Supplement: S001 · Decision Mar 1, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Occluder, Internal Vessel, Temporary
    Trade Name
    LEGOO ENDOVASCULAR OCCLUDER
    PMA Number
    P110003
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    OBC
    Generic Name
    Occluder, internal vessel, temporary
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 1, 2012
    Date Received
    November 15, 2011
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO A STERILIZATION PROCESS PARAMETER.

    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