|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.|
|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 curing time during the manufacturing process for the senserter, which is a component of the paradigm real-time system, paradigm real-time revel system, guardian real-time cgm system, minilink real-time system, and ipro2 professional cgm system.