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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.
 
DeviceMedtronic MiniMed 67G Insulin Pump
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160017
Supplement NumberS019
Date Received09/14/2017
Decision Date10/11/2017
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  
New manufacturing process to allow printed circuit board assemblies to be harvested and re-used for construction of refurbished and loaner 630G and 670G insulin pumps. The 630G and 670G insulin pumps are components of the MiniMed 630G and MiniMed 670G systems, respectively.
Post-Approval StudyShow Report Schedule and Study Progress
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