|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Updates to the manufacturing steps and fixtures at manufacturing station p09 "y block to shaft assembly" used in the manufacture of the arctic front and arctic front advance catheters.