PMA supplement
P160048 S008: Eversense Continuous Glucose Monitoring System
FDA PMA supplement · Real-Time Process · Senseonics, Incorporated
Key facts
| Original PMA | P160048 |
|---|---|
| Supplement number | S008 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Eversense Continuous Glucose Monitoring System |
| Generic name | Continuous glucose monitor, implanted, adjunctive use |
| Applicant | Senseonics, Incorporated |
| Product code | QCD |
| Received date | Dec 11, 2018 |
| Decision date | Jan 28, 2019 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: