|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||PARADIGM REAL TIME INSULIN PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR.|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
New tool to be used in the process of curing the vibrator motor to the vibrator motor housing in the paradigm real-time insulin pump (models: mmt-522, mmt-522k, mmt-722, mmt-722k), a component of the paradigm real-time continuous glucose monitoring system, the paradigm real-time revel insulin pump (models: mmt-523, mmt-523k, mmt-723, mmt-723k), a component of the paradigm real-time revel continuous glucose monitoring system, and the guardian real-time continuous glucose monitoring system.