BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P830061 · Supplement: S034 · Decision Jul 23, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    CAPSURE SENSE LEAD MODELS
    PMA Number
    P830061
    Supplement Number
    S034
    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
    July 23, 2002
    Date Received
    March 1, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PACING LEADS THAT INCORPORATE A NEW SURFACE COATING, A NEW ELECTRODE GEOMETRY, A NEW COMBINATION OF PREVIOUSLY USED STEROIDS, AND A NEW TAPERED STYLET. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES CAPSURE SENSE LEAD MODELS 4074/4574/4073 AND THE VITATRON CRYSTALLINE LEAD MODELS ICM09B, ICM09JB, AND ICM09. THESE DEVICES ARE INDICATED FOR PACING OR SENSING IN THE ATRIUM OR VENTRICLE. THE LEADS HAVE APPLICATION WHERE IMPLANTABLE ATRIAL OR VENTRICULAR SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED.

    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