|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 PUMP, PARADIGM REAL-TIME REVEL UNSULIN PUMP|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for design changes to the drive support cap, case bottom bore and additional glue for the paradigm real-time insulin pumps (mmt-722, mmt-722k) and paradigm real-time revel insulin pump (mmt-723, mmt-723k), as components of the paradigm real-time and paradigm real-time revel system.