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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 SENSOR
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS066
Date Received04/20/2015
Decision Date05/15/2015
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  
INCREASE IN THE SHELF LIFE FOR THE ENLITE GLUCOSE SENSORSUBASSEMBLY (SENSOR BASE AND CAPS) AFTER PLASMA TREATMENT, AND AN INCREASE IN THE LOAD (NUMBER)OF TREATED ENLITE SENSOR SUBASSEMBLIES PER PLASMA TREATMENT CYCLE. THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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