Eustachian tube balloon dilation system. Medical equipment (ICS: 11.040)

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System (3 pages, in English)

The Food and Drug Administration (FDA) is classifying theEustachian tube balloon dilation system into class II (special controls). The special controlsthat will apply to the device are identified in this order and will be part of the codifiedlanguage for the Eustachian tube balloon dilation system's classification. The Agency isclassifying the device into class II (special controls) in order to provide a reasonableassurance of safety and effectiveness of the device.