BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P850089 · Supplement: S033 · Decision Dec 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    CAPSURE Z MODELS 5034/5534/5033 PACING LEADS
    PMA Number
    P850089
    Supplement Number
    S033
    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
    December 21, 1995
    Date Received
    April 6, 1995
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODELS 5034, 5534, 5033 PACING LEADS - THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES CAPSURE Z MODEL 5-34, 5534, AND 5033 PACING LEADSAND HAVE APPLICATIONS WHERE PERMANENT VENTRICULAR, ATRIAL, OR DUAL CHAMBERED PACING SYSTEMS ARE INDICATED. THE LEADS ARE USED TO PROVIDE CHANNELED, ELECTRICALLY CONDUCTIVE PATHWASY BETWEEN THE PULSE GENERATOR AND THE HEART

    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