Continuous Glucose Monitor, Implanted, Adjunctive Use
QCD · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QCD
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
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.