|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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in design of the ept-1000 xp cardiac ablation controller. The change in design incorporates the originally approved ept-1000 xp controller with track while ablate (twa) technology to visualize catheter navigation during rf energy delivery using the real time position management (rpm) system. The device, as modified, will be marketed under the trade name track while ablate (twa) ept-1000 xp cardiac ablation system. The twa ept-1000 xp cardiac ablation controller and accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.