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The Tracker / August 2026 / P250018

PMA approved

RefluxStop® Device and RefluxStop® Deployment Tool

Implantica CE Reflux , Ltd. · Aug 20, 2026 · P250018

FDA approved the RefluxStop® Device and RefluxStop® Deployment Tool from Implantica CE Reflux , Ltd. on Aug 20, 2026 under P250018, an original premarket approval. The device falls under product code LEI, Implant, Anti-Gastroesophageal Reflux as a Class 3 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 23, 2025. The decision came 423 days later.

This is the only decision on file for Implantica CE Reflux , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250018?

P250018 is the FDA PMA for RefluxStop® Device and RefluxStop® Deployment Tool, submitted by Implantica CE Reflux , Ltd.. FDA's decision date was Aug 20, 2026, under product code LEI (Implant, Anti-Gastroesophageal Reflux).

Who makes the RefluxStop® Device and RefluxStop® Deployment Tool?

Implantica CE Reflux , Ltd., based in San Gwann, is the applicant of record for P250018.

How long did the P250018 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Aug 20, 2026, 423 days later.

← All decisions in August 2026