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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceENLITE SENSOR
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC Inc.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325-1219
PMA NumberP120010
Supplement NumberS067
Date Received04/29/2015
Decision Date07/29/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE TO THE ENLITE SENSOR BASE COMPONENT OF THE ENLITE SENSOR.
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