BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P960013 · Supplement: S001 · Decision Mar 19, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
    PMA Number
    P960013
    Supplement Number
    S001
    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
    March 19, 1998
    Date Received
    September 24, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the use of Thermedics Tecothane T11075D-M for molded polyurethane components as a replacement for Pellethane 2363-75D. FDA also acknowledges your marketing of the Tenril DX Model 1388T/C lead, which is identical to the approved Model 1388t lead, except that it is packaged only with the clip-on tool accessory.

    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