|Trade Name||EPT-1000 XP RF ABLATION SYSTEMS|
|Classification Name||catheter, percutaneous, cardiac ablation, for treatment of atrial flutter|
|Generic Name||radiofrequency generator/cardiac ablation catheter|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing process which involved the use of an alternate biological indicator (bi) with a shorter labeled incubation time of four (4) hours for use in monitoring the eo sterilization cycles and sterilization process validation.