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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 NumberS027
Date Received06/24/2014
Decision Date07/24/2014
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 
Change in the concentration of a raw material used during manufacture of the enlitetm glucose sensor (mmt-7008) of the minimed 530g system and softm glucose sensor (mmt-7002, mmt-7003) of the paradigm® real-time system and paradigm® real-time revel system.