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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 Nameartificial pancreas device system, threshold suspend
ApplicantMEDTRONIC MINIMED
PMA NumberP120010
Supplement NumberS031
Date Received07/29/2014
Decision Date08/28/2014
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 of the enlite¿ glucose sensor (model numbers: mmt-7008a, mmt-7008b) to modify the sterilization process with respect to the sterilization dose and bioburden alert and action levels. The enlite¿ glucose sensor is a component of the minimed 530g system.
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