BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Esophageal Pacing

    PMA: P860008 · Supplement: S016 · Decision Aug 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    System, Esophageal Pacing
    Trade Name
    ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR/PREAMPLIFIER
    PMA Number
    P860008
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    LPA
    Generic Name
    SYSTEM, ESOPHAGEAL PACING
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 28, 1998
    Date Received
    May 19, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    The device is indicated for 1) the termination of supraventricular tachycardia (atrial flutter and re-entrant atrial or atrio-ventricular paroxysmal tachycardias) in children via an esophageal catheter electrode; 2) the acceleration of heart rate in adults via a Pill-Electrode as an alternative to exercise during diagnostic studies such as echocardiography or radionuclide ventriculography; and 3) use in patients who develop bradycardia during general anesthesia and require acceleration of heart rate.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LPA System, Esophageal Pacing