|Trade Name||MINIMED 530G SYSTEM|
|Classification Name||artificial pancreas device system, threshold suspend|
|Generic Name||artificial pancreas device system, threshold suspend|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for additional manufacturing testing to be performed on a different version of a component used in the manufacture of the minimed 530g insulin pump mmt-551, mmt-751 that is part of the minimed 530g system.