|Trade Name||THE DEXCOM SEVEN 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 modifications made to the receiver sub-component pcba and housing; manufacturing processes of the receiver to accommodate a revised pcba; and outsourcing of the alternative receiver manufacturing process.