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
| Device Type ID | 723 |
| Device Name | Continuous Glucose Monitor, Implanted, Adjunctive Use |
| Physical State | This Device Comprises A Subcutaneously Implanted Sensor Containing The Glucose Specific Biological Sensor, An Algorithm That Converts Sensor Signals Into Glucose Values, A Display Device That Provides Glucose Values To The User, And A Mechanism For T |
| Technical Method | Signals From An Implanted (subcutaneous) Glucose Specific Biological Sensor Are Algorithmically Converted To Glucose Values Which Are Provided To The User. |
| Target Area | Interstitial Fluid |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QCD |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 723 |
| Device | Continuous Glucose Monitor, Implanted, Adjunctive Use |
| Product Code | QCD |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Alarm System | 6 |
Difficult To Remove | 5 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 12 |