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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.
 
DeviceSimplera Sync Sensor
Generic NameSensor, Glucose, Invasive, Component of automated insulin delivery system
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP250012
Supplement NumberS009
Date Received02/20/2026
Decision Date03/19/2026
Product Code SFI 
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  
to add the Medtronic Northridge facility as an additional site for conducting post-sterilization quality testing for the Simplera Sync sensor. The Simplera Sync sensor is a component of the MiniMed 780G System
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