|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||DEXCOM SEVEN AND SEVEN PLUS SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the device labeling to include more emphasis on the alert to users about the potential for the tips of sensors breaking off and to provide recommendations to users regarding their actions should this occur.