FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sensor, Glucose, Invasive
PMA: P160007
·
Supplement: S058
·
Decision Jan 23, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Sensor, Glucose, Invasive
- Trade Name
- MiniMed Go app; Simplera sensor
- PMA Number
- P160007
- Supplement Number
- S058
- 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
- January 23, 2026
- Date Received
- November 24, 2025
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
for a predetermined change control plan (PCCP) regarding alternate primary user interfaces and maintaining compatibility with alternate display devices.
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 |