|Trade Name||ANIMAS VIBE SYSTEM|
|Classification Name||pump, infusion, insulin, to be used with invasive glucose sensor|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the manufacturing location and process for spray paint coating of the animas vibe insulin pump outer plastic base and cover. The animas vibe insulin pump is a component of the animas vibe system.