Device Dossier
Cardiac radio-frequency ablation system
Device Dossier for Cardiac radio-frequency ablation system (Cardiac radio-frequency ablation system, Class IIb, sponsor Boston Scientific). ARTG record,…
- GMDN category: Cardiac radio-frequency ablation system
Intended purpose
The Intellagen RF Generator and Remote Control Kits are intended for use during RF ablation therapy of the human heart. These kits are to be used in conjunction with specialized therapeutic catheters and a dispersive pad to create a closed electrical circuit capable of delivering specified doses of RF energy to the cardiac tissue.