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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 NumberS125
Date Received11/07/2018
Decision Date11/30/2018
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  
Use of the barcode labels for the material identification process for the Enlite Sensor components/assembly at Medtronic Puerto Rico Operations Company (MPROC) for the following systems: MiniMed 530G System, MiniMed 630G System with SmartGuard, iPro2 CGM System with Enlite Sensor, and Paradigm Real-Time Revel System.
Post-Approval StudyShow Report Schedule and Study Progress
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