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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 NumberS011
Date Received02/18/2014
Decision Date03/20/2014
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 MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) TO ADD A NEW SENSOR FABRICATION CONFIGURATION TO INCLUDE A 48-UP SENSOR MASK WHICH WILL BE MANUFACTURED BY A NEW VENDOR. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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