Device Dossier

Stimulator, electrical, cardiac, diagnostic

Device Dossier for Stimulator, electrical, cardiac, diagnostic (Stimulator, electrical, cardiac, diagnostic, Class IIb, sponsor Regional Health Care…

Intended purpose

Advantage-MR EP Recorder/Stimulator System (Advantage-MR) is intended to acquire, amplify, filter, digitize, display, and record electrical signals obtained during electrophysiological studies and related procedures. Signal types acquired include intracardiac electrograms and surface ECG. The system allows the user to monitor, review, store, and retrieve the data, as well as to perform caliper-type measurements of the waveforms. The system incorporates a stimulator intended for diagnostic cardiac stimulation during electrophysiological evaluation of the human heart. Advantage-MR can display and record data received from other medical devices typically used during these procedures, such as a compatible RF generator.

TGA Public Summary