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

    Occluder, Internal Vessel, Temporary

    PMA: P110003 · Supplement: S003 · Decision Nov 13, 2012
    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
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    OBC
    Generic Name
    Occluder, internal vessel, temporary
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 13, 2012
    Date Received
    October 19, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE PACKAGING CONFIGURATIONS BY REDUCING THE NUMBER OF TYVEK POUCHED CANNULAE PER SALES CARTON.

    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