|Trade Name||ATAKR(TM) RFCA SYSTEM|
|Classification Name||cardiac ablation percutaneous catheter|
|Generic Name||cardiac ablation percutaneous catheter|
|Supplement Type||special (immediate track)|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addtion of a graph showing the relationship of initial atakr power output to temperature set point during the ramp up period in temperature control mode and the addtion of a warning statement rearding proper connection techniqures when utilizing the atakr system with other catheter laboratory equipment.