BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P960013 · Supplement: S015 · Decision Feb 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC
    PMA Number
    P960013
    Supplement Number
    S015
    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
    February 7, 2006
    Date Received
    December 8, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST MODEL 1788 T, TENDRIL ST MODEL 1788TC, AND TENDRIL ST MODEL 1782TC. THE TENDRIL ST MODEL 1788 LEAD IS DESIGNED FOR PERMANENT SENSING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. THE TENDRIL ST MODEL 1782 LEAD IS DESIGNED FOR PERMANENT SENSING AND PACING IN THE RIGHT ATRIUM, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.

    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