FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sensor, Glucose, Invasive, Non-Adjunctive
PMA: P120005
·
Supplement: S065
·
Decision Sep 21, 2017
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Sensor, Glucose, Invasive, Non-Adjunctive
- Trade Name
- Dexcon G5 Mobile Continuous Glucose Monitoring System
- PMA Number
- P120005
- Supplement Number
- S065
- Device Class
- FDA Class 3
- Product Code
- PQF
- Generic Name
- Sensor, glucose, invasive, non-adjunctive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- September 21, 2017
- Date Received
- July 10, 2017
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for firmware modifications to the touchscreen receiver in the Dexcom G5 Mobile Glucose Monitoring System.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PQF | Sensor, Glucose, Invasive, Non-Adjunctive | FDA class 3 | Unknown |