|Trade Name||MYSENTRY SYSTEM, MYSENTRY MONITOR, MYSENTRY OUTPOST|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of a functional test during manufacture of the mysentry system (mmt-9100). The mysentry system (mmt-9100) consists of the mysentry monitor (mmt-9101) and mysentry outpost (mmt-9102) and is approved for use with the paradigm realtime revel system.