|Trade Name||THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Generic Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a minor design change which added a volume control to the audible output device to permit the user to vary the volume of the continuous beeping sound made during radiofrequency delivery of power.