|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 SYSTEMS|
|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 design revisions to the accessory software program to provide additional supplementary information to users on glucose trends and patterns downloaded to the program. The software program, as modified, will be marketed under the trade name dexcom data manager 3 (dm3) and is indicated for use by consumers to allow for the transfer of glucose data stored by the dexcom sts or seven systems into a personal computer (pc). The software modifications included several new features as identified in the submission.