FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Continuous Glucose Monitor, Implanted, Adjunctive Use
PMA: P160048
·
Supplement: S003
·
Decision Feb 1, 2019
Classifications
1
FEI Numbers
8
Registration Numbers
8
Basic Information
- Device Name
- Continuous Glucose Monitor, Implanted, Adjunctive Use
- Trade Name
- Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers
- PMA Number
- P160048
- Supplement Number
- S003
- Device Class
- FDA Class 3
- Product Code
- QCD
- Generic Name
- Continuous glucose monitor, implanted, adjunctive use
- Medical Specialty
- Unknown
- Advisory Committee
- Clinical Chemistry
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 1, 2019
- Date Received
- August 27, 2018
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval to add final packaging, storage, and distribution activities for the Eversense Continuous Glucose Monitoring System at Woodfield Distribution, LLC, Boca Raton, FL.
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 |
|---|---|---|---|
| QCD | Continuous Glucose Monitor, Implanted, Adjunctive Use | FDA class 3 | Unknown |