MDS · Sensor, Glucose, Invasive
· Class 3
Overview
| Product Code | MDS |
|---|---|
| Device Name | Sensor, Glucose, Invasive |
| Device Class | Class 3 |
| Review Panel |
Identification
The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P160007 | Guardian Connect system | Medtronic Minimed | Mar 8, 2018 | APPR |
| P150021 | FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | Sep 23, 2016 | APPR |
| P150029 | IPRO2 CGM SYSTEM WITH ENLITE SENSOR | Medtronic Minimed | Jun 17, 2016 | APPR |
| P150019 | PARADIGM REAL-TIME REVEL SYSTEM | Medtronic Minimed | Dec 7, 2015 | APPR |
| P120005 | DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM | Dexcom, Inc. | Oct 5, 2012 | APWD |
| P050020 | FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR | Abbott Laboratories | Mar 12, 2008 | APWD |
| P050012 | DEXCOM STS CONTINOUS MONITORS | Dexcom, Inc. | Mar 24, 2006 | APWD |
| P980022 | CONTINUOUS GLUCOSE MONITORING SYSTEM | Medtronic Minimed | Jun 15, 1999 | APPR |
Top Applicants
- Medtronic Minimed — 4 clearances
- Dexcom, Inc. — 2 clearances
- Abbott Diabetes Care, Inc. — 1 clearance
- Abbott Laboratories — 1 clearance
