Continuous Glucose Monitor, Implanted, Adjunctive Use
The Continuous Glucose Monitor, Implanted, Adjunctive Use is a fully implanted device intended to detect trends and track patterns in interstitial glucose values as an adjunct to complement, not replace, information from standard home blood glucose monitoring devices. It is classified as FDA Class 3, requiring Premarket Approval (PMA) due to the high risks associated with fully implanted continuous monitoring in diabetic patients. The product code is QCD with no assigned regulation number, reviewed by the Clinical Chemistry panel. This device carries an implant flag.
Basic Information
- Product Code
- QCD
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.