|Trade Name||ARCTIC FRONT AND ARCTIC FRONT ADVANCE CRYOABLATION CATHETERS|
|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 a change in the equipment used to perform in process testing of the pressure sensor integrated in the blood detector board, the leak detector wire, and the thermocouples and removal of a redundant upstream testing of the pressure sensor function.