Premarket Approval (PMA)

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.

• Device: Eversense® E3 Continuous Glucose Monitoring System
• Generic Name: Sensor, glucose, implanted, non-adjunctive use
• Applicant: Senseonics, Incorporated; 20451 Seneca Meadows Pkwy.; Germantown, MD 20876
• PMA Number: P160048
• Supplement Number: S016
• Date Received: 09/30/2020
• Decision Date: 02/10/2022
• Product Code: QHJ
• Docket Number: 22M-0171
• Notice Date: 02/15/2022
• Advisory Committee: Clinical Chemistry
• Clinical Trials: NCT03808376
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling