|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||DEXCON SEVEN AND SEVEN PLUS|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change from a single to four-cavity production mold as well as the addition of an alternative gate location for the sensor safety lock.