|Trade Name||THERAPY COOL PATH CATHETER (6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6 HOLE IRRIGATED), SAFIRE BLU SP|
|Classification Name||cardiac ablation percutaneous catheter|
|Applicant||ST. JUDE MEDICAL|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modification to the currently marketed 1500t9 series cardiac ablation generator. The device, as modified, will be marketed under the trade name ampere generator and is indicated for: the ampere generator is intended for use with compatible ablation catheters in creating endocardial lesions during cardiac ablation procedures to treat cardiac arrhythmias.