OYC · Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
· Class 3
Overview
| Product Code | OYC |
|---|---|
| Device Name | Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor |
| Device Class | Class 3 |
| Review Panel |
Identification
The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P140015 | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM | Tandem Diabetes Care, Inc. | Sep 8, 2015 | APPR |
| P130007 | ANIMAS VIBE SYSTEM | Animas Corp. | Nov 25, 2014 | APWD |
Top Applicants
- Animas Corp. — 1 clearance
- Tandem Diabetes Care, Inc. — 1 clearance
