BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S008 · Decision Dec 11, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GEM II MODEL 7273/GEM DR 7271/GEM II VR 7229 ICDS
    PMA Number
    P980016
    Supplement Number
    S008
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 11, 2000
    Date Received
    July 26, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES OF THE MEDTRONIC MODELS 7221, 7223, 7227, 7229, 7271 AND 7273.