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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 SENSORS
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS050
Date Received12/10/2014
Decision Date01/07/2015
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 TO THE LASER CUTTING SPEED OF THE RESONETICS GALVO LASER SYSTEM USED IN THE SENSOR FABRICATION PROCESS FOR THE ENLITE SENSOR. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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