Device Dossier
Cardiac mapping system
Device Dossier for Cardiac mapping system (Cardiac mapping system, Class IIa, sponsor Microport Crm). ARTG record, intended purpose, GMDN category —…
- GMDN category: Cardiac mapping system
Intended purpose
The intended use of the Columbus 3D is catheter-based cardiac electrophysiological (EP) procedures. The device can assist the doctor to diagnose during the electrophysiological operation. And the Columbus 3D provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.