|Trade Name||FRESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Generic Name||sensor, glucose, invasive|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the quality system drawings of ten receiver and transmitter components, used for first article inspection activities prior to release for manufacturing.