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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 GLUCOSE SENSOR, ENLITE GLUCOSE SENSOR (MMT-7008)
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMEDTRONIC Inc.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325-1219
PMA NumberP120010
Supplement NumberS021
Date Received04/11/2014
Decision Date07/10/2014
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO LOWER THE PURITY SPECIFICATION LIMIT FOR THE CHROMIUMLAYER ON ENLITE¿ GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOF¿ GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM REAL-TIME REVEL SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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