PMA supplement
P160048 S029: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Senseonics, Incorporated
Key facts
| Original PMA | P160048 |
|---|---|
| Supplement number | S029 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic name | Sensor, glucose, implanted, non-adjunctive use |
| Applicant | Senseonics, Incorporated |
| Product code | QHJ |
| Received date | Feb 25, 2025 |
| Decision date | Mar 27, 2025 |
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: