|Trade Name||EPT-1000 XP CARDIAC ABLATION SYSTEM|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Generic Name||radiofrequency generator/cardiac ablation catheter|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the blazer xp rpm catheter which combines the features of the blazer ii xp with the real time position management (rpm) tracking system technology approved for the chilli rpm catheter.