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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 Nameartificail pancreas device system, threshold suspend
Applicant MEDTRONIC INC.
PMA NumberP120010
Supplement NumberS002
Date Received11/07/2013
Decision Date12/06/2013
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Type Special Supplement
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of product specification requirements for the glucose oxidase material used in the sof-sensors (models: mmt-7002 and mmt-7003) and the enlite sensor (model: mmt-7008).
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