PMA P160048S024

Device: Eversense E3 CGM System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S024
Product code: QHJ
Decision date: 2023-05-10
Classification: Clinical Chemistry
Generic name: Sensor, glucose, implanted, non-adjunctive use
Approval order statement: Addition of a new supplier for a critical component of the Eversense E3 Transmitter. The transmitter is a component of the Eversense Continuous Glucose Monitoring System.

Current openFDA PMA Record#

Device: Eversense E3 CGM System
Applicant: Senseonics, Incorporated
PMA number: P160048
Supplement: S024
Product code: QHJ
Generic name: Sensor, glucose, implanted, non-adjunctive use
Decision date: 2023-05-10
Decision code: OK30
Date received: 2023-04-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of a new supplier for a critical component of the Eversense E3 Transmitter. The transmitter is a component of the Eversense Continuous Glucose Monitoring System.