FDA PMA

Drug-eluting sinus stent

PMA Number: P100044 · 2026-09-23

ApplicantIntersect Ent.

Decision Date2026-09-23

PMA NumberP100044

Product CodeOWO

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeEN

Device Summary

Drug-eluting sinus stent is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Ent.. It received FDA 510(k) clearance on 2026-09-23. The device is classified under product code OWO. It was reviewed by the EN advisory panel.

Frequently Asked Questions

What is the Drug-eluting sinus stent?

Drug-eluting sinus stent is a medical device that received FDA 510(k) clearance on 2026-09-23. The listed applicant is Intersect Ent..

When did Drug-eluting sinus stent receive FDA 510(k) clearance?

The clearance date for Drug-eluting sinus stent can be found in the official FDA records.

Who is the listed applicant for Drug-eluting sinus stent?

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

What is the FDA product code for Drug-eluting sinus stent?

The FDA product code for Drug-eluting sinus stent is OWO.

Related Clinical Trials

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Official Source

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