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 Continuous Glucose Monitoring System
• Generic Name: Continuous glucose monitor, implanted, adjunctive use
• Applicant: Senseonics, Incorporated; 20451 Seneca Meadows Pkwy.; Germantown, MD 20876
• PMA Number: P160048
• Supplement Number: S005
• Date Received: 09/11/2018
• Decision Date: 12/07/2018
• Product Code: QCD
• Advisory Committee: Clinical Chemistry
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for a new LED for the Eversense sensor’s optical system.