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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 NumberS024
Date Received06/02/2014
Decision Date02/19/2015
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval changes to the design and manufacturing of the needle for the medtronic minimed 530g system enlite glucose sensor (mmt-7008a, mmt- 7008b); the specifically proposed changes which influence the enlite needle to introduce a bevel at the needle tip and increase needle sharpness.
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