|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||THERAPY COOL PATH DUO ABLATION CATHETER, SAFIRE BLU DUO ABLATION CATHETER AND 1500TP-CP V1.6 CARDIAC ABLATION GENERATOR|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Applicant||ST. JUDE MEDICAL, INC.|
|Supplement Type||135 review track for 30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an alternate vendor to supply printed circuit boards for the 1500t9-cp v1. 6 generator.