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