Device Dossier
Integrated Mapping System - Cardiac mapping system
Device Dossier for Integrated Mapping System - Cardiac mapping system (Cardiac mapping system, Class IIb, sponsor Medtronic). ARTG record, intended…
- GMDN category: Cardiac mapping system
Intended purpose
A mapping system is intended to be used for catheter-based cardiac electrophysiological mapping. The mapping system allows pacing and real-time visualization of compatible catheters as well as display of cardiac maps in multiple formats. The acquired patient signals, including body surface electrocardiograms and intracardiac electrograms, may also be recorded and displayed on the system’s display screen.