|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 |
Increase in the shelf life for the enlite glucose sensor subassembly (sensor base and caps) after plasma treatment, and an increase in the load (number) of treated enlite sensor subassemblies per plasma treatment cycle. The enlite glucose sensor is a component of the minimed 530g system.