|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 GLUCOSE SENSOR, SOF GLUCOSE SENSOR (MMT-7002, MMT-7003)|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to lower the purity specification limit for the chromium layer on enlite¿ glucose sensor (mmt-7008) of the minimed 530g system and sof¿ glucose sensor (mmt-7002, mmt-7003) of the paradigm real-time revel system.