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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.
 
DeviceGuardian 4 Sensor
Generic NameSensor, Glucose, Invasive, Component of automated insulin delivery system
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP250012
Supplement NumberS002
Date Received08/15/2025
Decision Date10/09/2025
Product Code SFI 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Minimed Kentucky Distribution Center (aka UPS Supply Chain Solutions), 1860 Outer Loop #326, Louisville, KY 40219, USA, FEI 3006759904, for repacking and labeling.
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