|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||ANIMAS VIBE SYSTEM|
|Classification Name||pump, infusion, insulin, to be used with invasive glucose sensor|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for substitution of 4 components (memory, transistor, micro-processing unit, connector) on the printed circuit board (pcb) of the approved animas vibe insulin pump. One of the replacement components (micro-processing unit) requires a modification to the pcb layout.