|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 SENSOR|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Replacement of paper-based lot history records (lhrs) with electronic lhrs. The change implements camstar manufacturing execution system (mes), an electronic control system for managing and monitoring work-in process on a manufacturing floor.