|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 |
Changes to the fabrication process for the sof-sensor (mmt-7002). The sof-sensor is a component of the continuous glucose monitoring system, paradigm real-time system, paradigm real-time revel system, guardian real time cgm system, minilink real-time system, ipro recorder cgm system, and ipro 2 professional cgm system.