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 (CGM) System
• Generic Name: Sensor, glucose, implanted, non-adjunctive use
• Applicant: Senseonics, Incorporated; 20451 Seneca Meadows Parkway; Germantown, MD 20876-7005
• PMA Number: P160048
• Supplement Number: S021
• Date Received: 09/30/2022
• Decision Date: 03/29/2023
• Product Code: QHJ
• Docket Number: 23M-1261
• Notice Date: 04/27/2023
• Advisory Committee: Clinical Chemistry
• Clinical Trials: NCT03808376
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval for the Eversense® E3 Continuous Glucose Monitoring System for modifying the device to reduce the frequency of calibration.

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