|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||GUARDIAN REAL-TIME SYSTEM, PARADIGM REAL-TIME PUMP, PARADIGM REAL-TIME REVEL PUMP|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Reinstatement of the ayutthaya, thailand facility as an additional facility for the manufacture of printed circuit board assemblies and stack subassemblies used by medtronic minimed in the production of the paradigm real-time insulin pump (models mmt-522, mmt-522k, mmt-722, mmt-722k), paradigm real-time revel insulin pump (models mmt-523, mmt-523k, mmt-723, and mmt-723k)) and guardian real-time monitor (css7100, css7 100k). The paradigm real-time insulin pump, paradigm real-time revel insulin pump, and guardian real-time monitor are components of the devices.