|Trade Name||THERAPY COOL PATH ABLATION CATHETER|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Applicant||ST. JUDE MEDICAL|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a design modification to the bond between that catheter shaft and the extension tubing. Specifically, you propose to change the adhesive from loctite to urethane and to modify the contact hole from a circular to an octagonal shape.