|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||SOF SENSOR|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the concentration of a raw material used during manufacture of the enlitetm glucose sensor (mmt-7008) of the minimed 530g system and softm glucose sensor (mmt-7002, mmt-7003) of the paradigm® real-time system and paradigm® real-time revel system.