|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 GLUCOSE SENSOR, MMT-7002, MMT-7003|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Manufacturing process change which will incorporate the addition of process water to a once-diluted batch of platinum plating solution for the sof-sensor glucose sensors (models mmt-7002 and mmt-7003) that are components of the devices.