|Trade Name||FREESTYLE NAVIGATOR|
|Classification Name||sensor, glucose, invasive|
|Generic Name||continuous glucose monitor|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for two labeling modifications: 1) to modify a warning regarding use of the system in an environment where anesthetic gas is used to instead warn against use in environments that contain any combustible gas; and 2) to add language to the instructions for muting alarms to clarify when it is not recommended to do so and also to clarify when the system will go into abandon alarm mode when the alarms are muted.