BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980016 · Supplement: S004 · Decision Mar 5, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MEDTRONIC MODEL 6940 STERIOC ELUTING BIPOLAR IMPALNTABLE SCREW-IN VENTRICULAR/ATRIAL TRANSVENOUS LEAD
    PMA Number
    P980016
    Supplement Number
    S004
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 5, 1999
    Date Received
    February 8, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for use of the Model 6940 CapSureFix Ventricular/Atrial Transvenous Lead. The device, as modified will be marketed under the trade name Model 6940 CapSureFix Lead and is intended for single long-term use in the right ventricle or right atrium for pacing and sensing.