|Trade Name||FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Generic Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the inserter component housing of the freestyle cgms, to reduce the overall thickness in the shelves of the housing and a change to the manufacturing equipment used to mold the housing components.