PMA supplement
P160048 S021: Eversense® E3 Continuous Glucose Monitoring (CGM) System
FDA PMA supplement · Panel Track · Senseonics, Incorporated
Key facts
| Original PMA | P160048 |
|---|---|
| Supplement number | S021 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Eversense® E3 Continuous Glucose Monitoring (CGM) System |
| Generic name | Sensor, glucose, implanted, non-adjunctive use |
| Applicant | Senseonics, Incorporated |
| Product code | QHJ |
| Received date | Sep 30, 2022 |
| Decision date | Mar 29, 2023 |
| Docket number | 23M-1261 |
| Notice date | Apr 27, 2023 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: