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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificail pancreas device system, threshold suspend
PMA NumberP120010
Supplement NumberS006
Date Received11/08/2013
Decision Date12/05/2013
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product 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).