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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 NumberS022
Date Received04/14/2014
Decision Date05/14/2014
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 
Addition of an automated cleaning system for components used in the enlite sensor, which is a component of the minimed 530g system.