|Trade Name||ARCTIC FRONT CRYOABLATION CATHETER, ARCTIC FRONT ADVANCE CRYOABLATION CATHETER|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation|
|Applicant||MEDTRONIC CRYOCATH LP|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the implementation of an alternative procedure involving the inflation and deflation of balloons contained in the device during the manufacturing process.