BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P950037 · Supplement: S032 · Decision Mar 31, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    PROTOS DR/CLS, PROTOS VR/CLS, AXIOS DR, AXIOS D, AXIOS S, AXIOS SR, AND AXIOS SLR PULSE GENERATORS WITH PROGRAMMER SOFT
    PMA Number
    P950037
    Supplement Number
    S032
    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 31, 2004
    Date Received
    February 28, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING AXVX ADAPTIVE RATE PACING CAPABILITY TO THE PROTOS FAMILY OF PULSE GENERATORS, THE ADDITION OF THE DATA TRANSFER UTILITY SOFTWARE, AND MODIFICATIONS TO THE AXIOS FAMILY OF PULSE GENERATORS.

    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