FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Sensor, Glucose, Implanted, Non-Adjunctive Use
PMA: P160048
·
Supplement: S029
·
Decision Mar 27, 2025
Classifications
1
FEI Numbers
7
Registration Numbers
7
Basic Information
- Device Name
- Sensor, Glucose, Implanted, Non-Adjunctive Use
- Trade Name
- EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
- PMA Number
- P160048
- Supplement Number
- S029
- Device Class
- FDA Class 3
- Product Code
- QHJ
- Generic Name
- Sensor, glucose, implanted, non-adjunctive use
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 27, 2025
- Date Received
- February 25, 2025
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee Statement
Approval of the revised protocol for the post-approval study (PAS) protocol.
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 |
|---|---|---|---|
| QHJ | Sensor, Glucose, Implanted, Non-Adjunctive Use | FDA class 3 | Unknown |