|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 SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM AND GUARDIAN REAL-TIME CGM SYSTEM|
|Classification Name||sensor, glucose, invasive|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Pc-based manufacturing software update from version 2. 2a to version 2. 3a at the medtronic minimed, northridge facility, and update from version 2. 0d to version 2. 3a at the mproc, juncos facility for the paradigm real-time insulin pump (models: mmt-522, mmt-522k, mmt-722, and mmt-722k), the paradigm real-time revel insulin pump (models: mmt-523, mmt-523k, mmt-723, and mmt-723k), the guardian real-time monitor (model: css7100) and the minimed 530g insulin pump (models mmt-551 and mmt-751).