|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: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested a change in the manufacturing (sterilization) process for therapeutic ablation catheters used with the ept-1000 that will allow the use of alternate biological indicators with a reduced incubation time.