|Trade Name||ENLITE GLUCOSE SENSOR|
|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) to add a new sensor fabrication configuration to include a 48-up sensor mask which will be manufactured by a new vendor. The enlitetm glucose sensor is a component of the minimed 530g system.