Device typeIntracardiac pacemaker: A battery-powered, hermetically-sealed pulse generator impregnated with a steroid (e.g., dexamethasone) intended to be implanted with a catheter, via transvenous access, into the right ventricle (i.e., single-chamber pacing) of an arrhythmic heart to generate/conduct electrical impulses to improve cardiac output. It contains sensors to detect changes in the body (e.g., motion, breathing frequency) and to adjust the pacing rate accordingly (rate-responsive). Wireless telemetry with external devices enables programming adjustments and may allow on-going heart monitoring; it does not provide defibrillation therapy. Disposable devices associated with implantation may be included.
FDA categoryLeadless pacemaker
Device ID00763000078645
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Catheter Working Length105.0 Centimeter
Catheter Gauge23.0 French