PMA
P160048: EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA PMA · Continuous glucose monitor, implanted, adjunctive use · Senseonics, Incorporated
Key facts
| PMA number | P160048 |
|---|---|
| Trade name | EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM |
| Generic name | Continuous glucose monitor, implanted, adjunctive use |
| Applicant | Senseonics, Incorporated |
| Owner/operator | Senseonics, Inc. |
| Product code | QCD |
| Approval date | Jun 21, 2018 |
| Docket number | 18M-2463 |
| Notice date | Jul 24, 2018 |
| Establishment registration | 3009862700 |
| FEI number | 3009862700 |
At a glance
- 10–99 Supplements
- Mar 19, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: