FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sensor, Glucose, Invasive
PMA: P120005
·
Supplement: S089
·
Decision Dec 21, 2021
Classifications
1
FEI Numbers
23
Registration Numbers
23
Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- G5 Mobile Continuous Glucose Monitoring System
- PMA Number
- P120005
- Supplement Number
- S089
- Device Class
- FDA Class 3
- Product Code
- MDS
- Generic Name
- Sensor, glucose, invasive
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 21, 2021
- Date Received
- September 29, 2021
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for the modification of the G5 Mobile Android Continuous Glucose Monitoring (CGM) Application software used with the G5 Mobile CGM 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 |
|---|---|---|---|
| MDS | Sensor, Glucose, Invasive | FDA class 3 | Unknown |