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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 Nameartificial pancreas device system, threshold suspend
PMA NumberP120010
Supplement NumberS056
Date Received01/06/2015
Decision Date03/20/2015
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional manufacturing testing to be performed on a different version of a component used in the manufacture of the minimed 530g insulin pump mmt-551, mmt-751 that is part of the minimed 530g system.