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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
Generic NameSensor, Glucose, Invasive, Component of automated insulin delivery system
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP250012
Supplement NumberS011
Date Received06/22/2026
Decision Date07/21/2026
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  
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