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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.
 
DeviceMINIMED 530G SYSTEM
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS070
Date Received06/09/2015
Decision Date02/18/2016
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
Supplement TypeNormal 180 Day Track
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 replacing the Enlite Serter (MMT-7510) with the 1-Press Serter (MMT-7512), the blue charger (MMT-7705) in the current MiniLink Transmitter Kit (MMT-7725NA) with the grey charger (MMT-7715) and the use of one watertight tester instead of two in the MiniLink Transmitter Kit.
Post-Approval StudyShow Report Schedule and Study Progress
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