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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.
 
DeviceEVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namecontinuous glucose monitor, implanted, adjunctive use
Generic Namecontinuous glucose monitor, implanted, adjunctive use
Applicant
Senseonics, Incorporated
20451 seneca meadows parkway
germantown, MD 20876-7005
PMA NumberP160048
Date Received10/26/2016
Decision Date06/21/2018
Product Code
QCD[ Registered Establishments with QCD ]
Docket Number 18M-2463
Notice Date 07/24/2018
Advisory Committee Clinical Chemistry
Clinical Trials NCT02154126
NCT02647905
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for The Eversense CGM System. The device is indicated for continually measuring glucose levels in adults (18 years and older) with diabetes for up to 90 days.The system is intended to:1) Provide real-time glucose readings;2) Provide glucose trend information; and3) Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time.The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 
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