|Trade Name||FREESTYLE NAVIGATOR CONTIUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Generic Name||continuous glucose monitor|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an updated version of the copilot health management system for freestyle navigator labeling and help files in the application to add windows vista as an operating system that the application can be installed on as well as adding the necessary steps to allow the application and device to be used with vista.