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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 NumberS011
Date Received02/18/2014
Decision Date03/20/2014
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 manufacturing process for the enlitetm glucose sensor (model numbers: mmt-7008a, mmt-7008b) to add a new sensor fabrication configuration to include a 48-up sensor mask which will be manufactured by a new vendor. The enlitetm glucose sensor is a component of the minimed 530g system.