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- PQFSensor, Glucose, Invasive, Non-Adjunctive3Product Code
- PZESensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated3Product Code
- QCDContinuous Glucose Monitor, Implanted, Adjunctive Use3Product Code
- QHJSensor, Glucose, Implanted, Non-Adjunctive Use3Product Code
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- SCJLdt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final RuleNProduct Code
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Continuous Glucose Monitor, Implanted, Adjunctive Use
- Page Type
- Product Code
- 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.
- 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 transmitting data from the sensor to the display device.
- 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
- Chemistry
- Submission Type
- PMA
- Device Classification
- Class 3
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
The FDA has not linked product code QCD to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:
- The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
- The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
- The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.