Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about PMA

New Search Back to Search Results
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.
 
DeviceEversense® E3 Continuous Glucose Monitoring System
Generic NameSensor, glucose, implanted, non-adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown, MD 20876
PMA NumberP160048
Supplement NumberS016
Date Received09/30/2020
Decision Date02/10/2022
Product Code QHJ 
Docket Number 22M-0171
Notice Date 02/15/2022
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02154126
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Eversense® E3 Continuous Glucose Monitoring System for expanding the indications for use and modifying the sensor design to allow use for up to 180 days.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
  We welcome your comments and feedback about Devices@FDA.
-
-