QCD · Continuous Glucose Monitor, Implanted, Adjunctive Use
· Class 3
Overview
| Product Code | QCD |
|---|---|
| Device Name | Continuous Glucose Monitor, Implanted, Adjunctive Use |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P160048 | EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM | Senseonics, Incorporated | Jun 21, 2018 | APPR |
Top Applicants
- Senseonics, Incorporated — 1 clearance
