|Trade Name||ENLITE GLUCOSE SENSOR, ENLITE SERTER|
|Classification Name||artificial pancreas device system, threshold suspend|
|Generic Name||artificial pancreas device system, threshold suspend|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the manufacturing process for the enlitetm glucose sensor (model numbers: mmt-7008a, mmt-7008b) by adding an additional step during the assembly procedure and an inspection step during the packaging procedure. The enlitetm glucose sensor is a component of the minimed 530g system.