BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P960013 · Supplement: S009 · Decision Dec 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    TENDRIL SDX
    PMA Number
    P960013
    Supplement Number
    S009
    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 7, 2000
    Date Received
    November 16, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE SUTURE SLEEVES USED WITH THE PACEMAKER LEADS: THE INCORPORATION OF TITANIUM DIOXIDE INTO THE SUTURE SLEEVE MATERIAL TO MAKE THE MATERIAL "MORE VISIBLE DURING IMPLANT"; INCREASING THE INNER DIAMETER OF THE SLEEVE AND; REMOVEL OF THE SLEEVE EYELET'S.

    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