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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 NumberS041
Date Received10/30/2014
Decision Date01/28/2015
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MINOR DESIGN CHANGES TO THE SENSOR BASE, O-RING, TAPE, ADHESIVE AND SENSOR PATCH OF THE ENLITE GLUCOSE SENSOR (MMT-7008A, MMT-7008B) IN ORDER TO SUPPORT MANUFACTURING CHANGES FROM A MANUAL ASSEMBLY PROCESS TO AN AUTOMATED ASSEMBLY LINE FOR THE ENLITE GLUCOSE SENSOR. THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530GSYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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