|Trade Name||ENLITE SENSOR|
|Classification Name||artificial pancreas device system, threshold suspend|
|Generic Name||artificail 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 adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (gox) performed by the supplier for use in the sponsor¿s enlite sensor (model: mmt-7008) and sof-sensor (models: mmt-7002 and mmt-7003) devices. The enlite sensor is a component of the minimed 530g system. The sof-sensor is a component of the paradigm real-time, paradigm realtime revel, guardian real-time, minilink real-time, ipro recorder and ipro2 professional continuous glucose monitoring systems.