Dexcom G5 Mobile Continuous Glucose Monitoring System
FDA PMAClass III (US FDA PMA)
by Dexcom, Inc.
Identity
- Trade Name
- DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM FDA PMA
- Generic Name
- Sensor, glucose, invasive FDA PMA
Identifiers
- PMA Number
- P120005 FDA PMA
- FDA Product Code
- MDS FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Clinical Chemistry FDA PMA
- FDA Decision
- APWD FDA PMA
The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose sensor, invasive, designed for detecting glucose trends and tracking patterns in individuals aged 18 and older with diabetes. This system provides real-time glucose monitoring via an implanted sensor, enabling continuous assessment of blood glucose levels without frequent fingerstick tests.
Intended for single-patient use and requiring a prescription, the system operates as an adjunct to standard home glucose monitoring devices. It aids in identifying episodes of hyperglycemia and hypoglycemia, supporting acute and long-term therapy adjustments. The device is approved for FDA_PMA under PMA number P120005 and is classified as a Class III medical device. Supplied as a reusable transmitter paired with single-use sensors, it is not MRI-safe and must be stored according to manufacturer guidelines.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Dexcom Continuous Glucose Monitoring | Dexcom CGM | Dexcom, Dexcom – Wikipedia, Dexcom CGM-Systeme | DIASHOP, Die Alternative zum Fingerstich*: Dexcom Flex | Dexcom
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P120005 | Class III | Active |
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Manufacturer
- Manufacturer
- Dexcom, Inc.
Sources (1)
- FDA PMA P120005 24 fields · synced Sep 18, 2026