PMA P160048S023

Device: Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S023
Product code: QHJ
Decision date: 2023-03-22
Classification: Clinical Chemistry
Generic name: Sensor, glucose, implanted, non-adjunctive use
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device: Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S023
Product code: QHJ
Generic name: Sensor, glucose, implanted, non-adjunctive use
Decision date: 2023-03-22
Decision code: APPR
Date received: 2023-02-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the revised protocol for the post-approval study (PAS) protocol.