|Trade Name||DEXCOM SEVEN AND SEVEN PLUS SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Generic Name||sensor, glucose, invasive|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a proposed change to remove redundant destructive testing for bond strength of three applicator components (cannula carrier, push rod carrier, and sensor needle carrier) of the devices.