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In Brief: Ohmeda I-NOvent:

This article was originally published in The Gray Sheet

Executive Summary

Ohmeda I-NOvent: FDA's Anesthesiology and Respiratory Therapy Devices Panel recommends downclassification from Class III to Class II with special controls of Ohmeda's system for nitric oxide administration at a Nov. 22 meeting in Rockville, Maryland. Ohmeda submitted a downclassification petition to FDA in September. I-NOvent, which comprises a nitric oxide administration apparatus and two separate devices to monitor nitric oxide gas and nitric dioxide gas concentration, is intended for inhaled nitric oxide therapy to treat pulmonary hypertension and lung disease conditions. FDA expects to publish a draft guidance on nitric oxide therapy systems in early 1997...

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