Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
Information
Type
Rule
Regulated products
Medical Devices
Published
October 24, 2016
Last updated
October 24, 2016
Description
Document number 2016-25602. The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the Eustachian tube balloon dilation system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)