BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980035 · Supplement: S006 · Decision Dec 20, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC.KAPPA 700/600 SERIES OF PACEMAKERS
    PMA Number
    P980035
    Supplement Number
    S006
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 1999
    Date Received
    December 6, 1999
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a correction to the shipping box label for the Model KDR 721 pacemaker properly identifying the contents as a "Dual Chamber Rate Responsive Pacemaker."