BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P960006 · Supplement: S016 · Decision Aug 4, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    FLEXTEND FAMILY OF PACING LEADS
    PMA Number
    P960006
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 4, 2005
    Date Received
    July 5, 2005
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF PRIMER TO THE INNER SURFACE OF THE ELECTRODE RING OF THE FLEXTEND LEADS TO INCREASE ADHESION OF THE ELECTRODE RING TO THE MOLDED NECK.

    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