|Trade Name||ENLITE 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: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Removal of a conductivity test for a solution used on the manufacture of enlite sensors, the creation of a new part number for this solution and the removal of alternate part number allowed for enlite sensors manufacture. The enlite sensor is a component of the minimed 530g system.