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FDA PMA

IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX

PMA Number: P100049 · 2026-01-16

ApplicantTorax Medical
Decision Date2026-01-16
PMA NumberP100049
Product CodeLEI
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeGU

Device Summary

IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX is the device name listed in this FDA 510(k) record. The listed applicant is Torax Medical. It received FDA 510(k) clearance on 2026-01-16. The device is classified under product code LEI. It was reviewed by the GU advisory panel.

Frequently Asked Questions

What is the IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX?

IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Torax Medical.

When did IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX receive FDA 510(k) clearance?

The clearance date for IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX can be found in the official FDA records.

Who is the listed applicant for IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX?

The FDA 510(k) record lists Torax Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX?

The FDA product code for IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX is LEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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