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Eversense Continuous Glucose Monitoring System

FDA PMA

Class III (US FDA PMA)

PMA P160048

by Senseonics, Incorporated

Identity

Trade Name
EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM FDA PMA
Generic Name
Continuous glucose monitor, implanted, adjunctive use FDA PMA

Identifiers

PMA Number
P160048 FDA PMA
FDA Product Code
QCD FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Clinical Chemistry FDA PMA
FDA Decision
APPR Approved FDA PMA

The Eversense Continuous Glucose Monitoring System is an implanted, adjunctive continuous glucose monitor indicated for continually measuring glucose levels in adults (18 years and older) with diabetes. It provides real-time glucose readings, glucose trend information, and alerts for the detection and prediction of hypoglycemic and hyperglycemic episodes.

The system is a prescription device intended for use as an adjunct to standard home blood glucose monitoring. Historical data from the system can be interpreted to aid in therapy adjustments based on patterns over time. It is authorized under FDA PMA P160048 and is designed for up to 90 days of continuous use.

Frequently asked questions

What is the Eversense Continuous Glucose Monitoring System indicated for?

The Eversense Continuous Glucose Monitoring System is indicated for continually measuring glucose levels in adults (18 years and older) with diabetes for up to 90 days, as an adjunctive device to complement, not replace, standard home blood glucose monitoring.

How long can the Eversense CGM System be used continuously?

The Eversense CGM System is indicated for continual glucose measurement for up to 90 days, as stated in its approval documentation and indications for use.

Is the Eversense CGM System a standalone replacement for fingerstick glucose testing?

No, the Eversense CGM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices, meaning it should be used alongside, not instead of, fingerstick tests.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Das Eversense Glucose Monitoring (CGM) Diabetes System fürs …, Eversense Continuous Glucose Monitoring (CGM) Device | Glucose ..., Eversense CGM System | Long-Term Implantable CGM | Global, Eversense: Ein Langzeit-CGM für Diabetiker - GlucoseCode, Eversense XL für die Diabetes-Therapie - DiabSite

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Senseonics, Incorporated

Sources (1)

  • FDA PMA P160048 24 fields · synced Sep 18, 2026