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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 NumberS016
Date Received03/06/2014
Decision Date06/03/2014
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the software to the minimed 530g insulin pump (models mmt-551 and mmt-751). These changes include corrections for two motor error anomalies and three threshold suspend anomalies, and enhancements for the threshold suspend feature, insulin value setting, and merged common code base.