1. IFU005161 Rev A RELIEVA TRACT^® Balloon Dilation System ‐ Instructions for Use

Disclosures

Important Safety Information 

ACCLARENT^® Balloon Sinuplasty Devices are intended for use by or under the direction of a physician who is trained in the use of Acclarent Technology. ACCLARENT^® Balloon Sinuplasty Device use has described risks, including tissue and mucosal trauma, infection, or possible orbital injury. Prior to use, it is important to read the Instructions for Use and to understand the contraindications, warnings, and precautions associated with these devices, as well as all products mentioned on this resource.

Third party trademarks used herein are trademarks of their respective owners. This content is intended for audience within the US only.

Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.

The RELIEVA TRACT^® Nasal Balloon Dilation System is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. The RELIEVA TRACT^® Nasal Balloon Dilation System is intended for use in ages 17 years or older.

CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Balloon dilation catheters should be used by or under supervision of physicians thoroughly trained in balloon dilation. A thorough understanding of the technical principles, clinical application, and risk associated with balloon dilation of the nasal passage is necessary before using this device.

This site is published by Acclarent, Inc. which is solely responsible for its contents. It is intended for visitors from the United States.

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