CDRH: Anesthesiology and Respiratory Therapy Devices Panel

The committee will discuss, make recommendations and vote on a premarket approval application, sponsored by Emphasys Medical Inc., for the Emphasys Zephyr Endobronchial Valve System, which is intended to improve Forced Expiratory Volume in the first second (FEV1) and 6- minute walk test distance in patients with severe heterogeneous emphysema who have received optimal medical management.

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