Device Dossier
Cardiac mapping system
Device Dossier for Cardiac mapping system (Cardiac mapping system, Class IIa, sponsor Boston Scientific). ARTG record, intended purpose, GMDN category —…
- GMDN category: Cardiac mapping system
Intended purpose
The Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system display screen.