QCD — Continuous Glucose Monitor, Implanted, Adjunctive Use Class III
FDA product code QCD covers "Continuous Glucose Monitor, Implanted, Adjunctive Use", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- QCD
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- Yes
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.