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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSimplera Sync Sensor, Guardian 4 Sensor
Generic NameSensor, Glucose, Invasive, Component of automated insulin delivery system
ApplicantMedtronic Minimed, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP250012
Date Received04/18/2025
Decision Date08/06/2025
Product Code SFI 
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the Simplera Sync sensor and Guardian 4 sensor, intended to function as components of a Medtronic automated insulin dosing system.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling
Labeling Part 2
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
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