PMA P160048S022

Device: Eversense® E3 Continuous Glucose Monitoring (CGM) System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S022
Product code: QHJ
Decision date: 2023-03-30
Classification: Clinical Chemistry
Generic name: Sensor, glucose, implanted, non-adjunctive use
Approval order statement: Approval for modifying the Eversense E3 Transmitter, supporting mobile medical application, and the Instructions for Use for consistent use with the modified transmitter.

Current openFDA PMA Record#

Device: Eversense® E3 Continuous Glucose Monitoring (CGM) System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S022
Product code: QHJ
Generic name: Sensor, glucose, implanted, non-adjunctive use
Decision date: 2023-03-30
Decision code: APPR
Date received: 2023-01-31
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for modifying the Eversense E3 Transmitter, supporting mobile medical application, and the Instructions for Use for consistent use with the modified transmitter.