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Eustachian Tube Balloon Dilation Device

FDA product code PNZ · 8 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.4180
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-04-05 – 2026-02-19

The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.

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