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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NumberS059
Date Received04/01/2019
Decision Date05/01/2019
Product Code OZP 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of a second production line for the printed circuit board assembly (PCBA) component to increase manufacturing capacity for the Guardian Sensor (3) continuous lucose monitoring sensor. The Guardian Sensor (3) is a component of the MiniMed 630G, Guardian Connect System, and MiniMed 670G systems.
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