Device typeImplantable cardiac monitor: A hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events.
FDA categoryRECORDER,EVENT,IMPLANTABLE CARDIAC,(WITHOUT ARRHYTHMIA DETECTION)
Device ID05414734502573
Catalog numberDM2102
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional