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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.
 
Trade NameENLITE GLUCOSE SENSOR
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificail pancreas device system, threshold suspend
Applicant MEDTRONIC INC.
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.
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