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U.S. Department of Health and Human Services

Devices@FDA
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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
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS027
Date Received06/23/2014
Decision Date07/24/2014
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGE IN THE CONCENTRATION OF A RAW MATERIAL USED DURING MANUFACTURE OF THE ENLITETM GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOFTM GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM® REAL-TIME SYSTEM AND PARADIGM® REAL-TIME REVEL SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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