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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 SENSOR
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
ApplicantMEDTRONIC MINIMED
PMA NumberP120010
Supplement NumberS028
Date Received06/24/2014
Decision Date07/22/2014
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 to the needle hub assembly tooling which is used in the manufacture of the enlite sensor (mmt-7008). The enlite sensor (mmt-7008) is a component of the minimed 530g system.
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