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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.
 
DeviceMedtronic MiniMed 670G insulin pump, Medtronic MiniMed 770G insulin pump
Generic NameAutomated insulin dosing device system, single hormonal control
ApplicantMEDTRONIC MINIMED, INC.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325
PMA NumberP160017
Supplement NumberS098
Date Received03/29/2022
Decision Date04/28/2022
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
Approval Order Statement  
Manufacturing changes for the next generation pump (NGP) case assembly. The NGP case assembly is a component of the Medtronic MiniMed 630G, 670G, and 770G insulin pump systems.
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