|Trade Name||DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS)|
|Classification Name||catheter, coronary, atherectomy|
|Applicant||CARDIOVASCULAR SYSTEMS, INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of changes to the sterilization process, including an additional sterilization chamber, alternative configurations for process challenge devices, reduction in aeration time, and additional post-nitrogen washes and evacuations.