|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 the addition of an extender module to the accessory list for the generator. The extender module will allow the user to place the generator up to an additional twenty feet from the patients.