FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sensor, Glucose, Invasive, Non-Adjunctive
PMA: P120005
·
Supplement: S073
·
Decision Jul 3, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Sensor, Glucose, Invasive, Non-Adjunctive
- Trade Name
- G5 Mobile transmitter Hardware and Firmware, G5 Mobile Continuous Glucose Monitoring System
- PMA Number
- P120005
- Supplement Number
- S073
- 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
- July 3, 2018
- Date Received
- April 4, 2018
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for minor design changes to the Dexcom G5 transmitter hardware and firmware. The Dexcom G5 transmitter is part of the Dexcom G5 Mobile Continuous Glucose Monitoring System (CGM).
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 |