|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||SEVEN SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a design modification to allow users of the dexcom seven system dm2 data manager software to obtain receiver firmware updates electronically and remotely using their personal computer.