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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceZephyr Endobronchial Valve System
Classification Namevalve, pulmonary
Generic Namevalve, pulmonary
Applicant
Pulmonx Corporation
700 chesapeake drive
redwood city, CA 94063
PMA NumberP180002
Date Received01/02/2018
Decision Date06/29/2018
Product Code
NJK[ Registered Establishments with NJK ]
Docket Number 18M-2571
Notice Date 06/29/2018
Advisory Committee Anesthesiology
Clinical Trials NCT00129584
NCT01580215
NCT01796392
NCT02022683
NCT02025205
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the Pulmonx Zephyr® Endobronchial Valve System. The device is an implantable bronchial valve indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 
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