QHJ · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QHJ
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
Y
Third-party review
N
Definition
A non-adjunctive implanted glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.