|Trade Name||DEXCOM SEVEN & 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 eliminate redundant post-winding and post-second-parylene visual inspection for the sensor component of the seven and seven plus continuous glucose monitoring system.