Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
OYC · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
OYC
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
CH
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.