|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||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for 1) the addition of thermistor temperature sensor catheters to the therapy catheter model mix, 2) the addition of a 1763-e compatible interface cable to the 4mm thermistor ablation catheter, and 3) the addition of the 1778-e compatible interface cable to the 8mm thermistor ablation catheter.