|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; PARADIGM REAL-TIME REVEL INSULIN PUMP|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - specifications|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for design and manufacturing changes to the dscap and case bottom to include a metric thread interface for the paradigm real-time insulin pumps, paradigm real-time revel insulin pumps (model numbers mmt-522, 522k, 523, 523k, 722, 722k, 723, 723k), and minimed 530g insulin pumps (model numbers mmt-551, 751), which are components of the paradigm real-time and paradigm real-time revel continuous glucose monitoring system, and theminimed 530g system.