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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 Insulin Pump
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS116
Date Received04/30/2018
Decision Date05/30/2018
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 from a manual to an automated pull test system to decrease variability and increase production capacity for the Paradigm and 530G insulin pumps housing. The Paradigm insulin pumps are components of the Continuous Glucose Monitoring System, Paradigm REAL-Time Revel System, and Paradigm REAL-Time System and the MiniMed 530G pumps are components of the MiniMed 530G System.
Post-Approval StudyShow Report Schedule and Study Progress
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