|Trade Name||FREEZOR,FREEZOR XTRA & FREEZOR MAX CRYOABLATION DEVICES|
|Classification Name||cardiac ablation percutaneous catheter|
|Applicant||CRYOCATH TECHNOLOGIES, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the leak detection system in the freezor catheter and freezor xtra devices from a single bare stainless steel wire to a duplex insulated wire made of two electrodes.