|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 PUMP|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the implementation of a pneumatic press tool in place of a manual press tool in the manufacturing process 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, mmt-723k), guardian realtime monitor (models: css7100 and css17100k) and the minimed 530g insulin pump (models: mmt-551 and mmt-751). These parts are components of the paradigm real-time system, paradigm real-time revel system, guardian real-time continuous glucose monitoring systems and the minimed 530g system respectively.