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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 NumberS024
Date Received06/02/2014
Decision Date02/19/2015
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 CHANGES TO THE DESIGN AND MANUFACTURING OF THE NEEDLE FORTHE MEDTRONIC MINIMED 530G SYSTEM ENLITE GLUCOSE SENSOR (MMT-7008A, MMT- 7008B); THE SPECIFICALLY PROPOSED CHANGES WHICH INFLUENCE THE ENLITE NEEDLE TO INTRODUCE A BEVEL AT THE NEEDLE TIP AND INCREASE NEEDLE SHARPNESS.
Post-Approval StudyShow Report Schedule and Study Progress
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