|Trade Name||SOF-SENSOR GLUCOSE SENSOR, MMT-7002, MMT-7003|
|Classification Name||sensor, glucose, invasive|
|Generic Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|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-sensorglucose sensors (models mmt-7002 and mmt-7003) that are components of the devices.