|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.|
|Trade Name||EPT-1000 CARDIAC ABLATION SYSTEM|
|Applicant||EP TECHNOLOGIES, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes in the manufacturing operation: a change in the welding process from a manual to an automated process, a change in the grit blast media, and removal of a chemical to the weld joint.