|Trade Name||MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING|
|Classification Name||sensor, glucose, invasive|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing process change to incorporate the addition of process water to a used batch of platinum plating solution for the sof sensor glucose sensors (models mmt-7002 and mmt-7003) that are components of the medtronic minimed continuous glucose monitoring system, the paradigm real-time system, the guardian real-time system, the cgms ipro system and the cgms ipro2 system.