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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™ System
Generic NameSensor, glucose, invasive, non-adjunctive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325-1219
PMA NumberP160007
Supplement NumberS047
Date Received02/15/2023
Decision Date07/24/2024
Product Code PQF 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT04436822
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Simplera system. The Simplera system is a real-time continuous glucose monitoring (CGM) system indicated for the management of diabetes in persons ages 18 years and older. The Simplera system does not require calibration and is designed to replace fingerstick blood glucose (BG) testing for diabetes treatment decisions, unless otherwise indicated. Interpretation of the Simplera system results should be based on the glucose trends and several sequential sensor readings over time.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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