|Trade Name||ENLITE SENSOR|
|Classification Name||artificial pancreas device system, threshold suspend|
|Generic Name||artificial pancreas device system, threshold suspend|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the calculation method used to determine the amount of platinum to add in the manufacture of the platinum solution used in the fabrication process for the sof-sensor and enlite sensors, and for the enlite sensor only, the addition of equipment used to verify the platinum solution concentration.