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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 670G System
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160017
Supplement NumberS049
Date Received07/23/2018
Decision Date08/14/2018
Product Code OZP 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02130284
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  
Adding an alternative injection molding machine to produce the sleeve component used in the MiniMed 630G Pump and the MiniMed 670G Pump. The MiniMed 630G Pump is part of the MiniMed 630G System with SmartGuard and the MiniMed 670G pump is part of the MiniMed 670G System.
Post-Approval StudyShow Report Schedule and Study Progress
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