|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||SAFIRE BLU DUO SP ABLATION CATHETERS|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Applicant||ST. JUDE MEDICAL, INC.|
|Supplement Type||real-time process|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternative package configuration for the subject ablation catheters. The new package configuration would change the previous coiled tray configuration to a tray with a straight configuration. The device, as modified, will be marketed under the trade names safire blu sp irrigated ablation catheter, therapy cool path sp (bi-directional) ablation catheter, and safire blu duo sp ablation catheter.