FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Sensor, Glucose, Implanted, Non-Adjunctive Use
PMA: P160048
·
Supplement: S010
·
Decision Jul 24, 2019
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
- S010
- Device Class
- FDA Class 3
- Product Code
- QHJ
- Generic Name
- Sensor, glucose, implanted, non-adjunctive use
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- July 24, 2019
- Date Received
- June 24, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Modification of equipment and processes used to encase the Eversense sensor. The Eversense sensor is a component of the Eversense Continuous 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 |
|---|---|---|---|
| QHJ | Sensor, Glucose, Implanted, Non-Adjunctive Use | FDA class 3 | Unknown |