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 Parkway; Germantown, MD 20876-7005
• PMA Number: P160048
• Supplement Number: S019
• Date Received: 04/26/2022
• Decision Date: 05/24/2022
• Product Code: QHJ
• Advisory Committee: Clinical Chemistry
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.