FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Sensor, Glucose, Implanted, Non-Adjunctive Use
PMA: P160048
·
Supplement: S013
·
Decision Aug 29, 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
- S013
- 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
- August 29, 2019
- Date Received
- July 31, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
New manufacturing site for the electronics assembly and encasement process for the sensor 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 |