FDA Product Code PNZ: Eustachian Tube Balloon Dilation Device
Chronic Eustachian tube dysfunction causes ear pressure, hearing loss, and recurrent otitis media. FDA product code PNZ covers Eustachian tube balloon dilation devices.
These devices are inserted through the nose and nasopharynx to dilate the cartilaginous Eustachian tube using an inflatable balloon, improving tube function and ventilation of the middle ear in patients with chronic Eustachian tube dysfunction who have failed medical therapy.
PNZ devices are Class II medical devices, regulated under 21 CFR 874.4180 and reviewed by the FDA Ear, Nose & Throat panel.
Leading manufacturers include Acclarent, Inc., Medtronic Xomed, Inc. and Entellus Medical, Inc..
FDA 510(k) Cleared Eustachian Tube Balloon Dilation Device Devices (Product Code PNZ)
About Product Code PNZ - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PNZ since 2016, with 8 receiving FDA clearance (average review time: 179 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under PNZ have taken an average of 93 days to reach a decision - down from 189 days historically, suggesting improved FDA processing for this classification.
PNZ devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →