|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.|
|Classification Name||cardiac ablation percutaneous catheter|
|Applicant||METRONIC CRYOCATH LP|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for installation of four new catheter recognition files, as well as labeling changes to the cryoconsole operator¿s manual.