PMA
P250018: RefluxStop® Device and RefluxStop® Deployment Tool
FDA PMA · IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX · Implantica CE Reflux, Ltd.
Key facts
| PMA number | P250018 |
|---|---|
| Trade name | RefluxStop® Device and RefluxStop® Deployment Tool |
| Generic name | IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX |
| Applicant | Implantica CE Reflux , Ltd. |
| Product code | LEI |
| Approval date | Aug 20, 2026 |
At a glance
- None Supplements
- Aug 20, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: