|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, PARADIGN REAL TIME REVEL INSULIN PUMP|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an alternate facility warehouse space for the handling of raw materials including subassemblies and components for the paradigm real-time insulin pumps (mmt-522, mmt-522k, mmt-722, mmt-722k) and paradigm real-time revel insulin pumps (mmt-523, mmt-523k, mmt-723, mmt-723k). The paradigm real-time insulin pumps are components of the paradigm real-time system and the paradigm real-time revel insulin pumps are components of the paradigm real-time revel system.