|Trade Name||FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Generic Name||continuous glucose monitor|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the cleaning procedure of the reactors used to make the npbi mediator chemical used in the freestyle test strips and the time frame in which this cleaning process takes place.