BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P120017 · Decision Apr 27, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    MODEL 5071 LEAD
    PMA Number
    P120017
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 27, 2015
    Date Received
    October 4, 2012
    Expedited Review
    N
    Docket Number
    15M-1461

    Advisory Committee Statement

    APPROVAL FOR UNIPOLAR VENTRICULAR PACING AND SENSING. THE LEAD HASAPPLICATION WHERE PERMANENT VENTRICULAR OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED. TWO LEADS MAY BE USED FOR BIPOLAR PACING.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTB Permanent Pacemaker Electrode