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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
Applicant MEDTRONIC INC.
PMA NumberP120010
Supplement NumberS063
Date Received02/26/2015
Decision Date03/23/2015
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 
Modification to the laser cutting parameters for the potomac laser system used during the enlite sensor manufacturing process in order to qualify it for use with the 48-up sensor configuration. The enlite sensor is a component of the minimed 530g system.
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