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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
Generic NameValve, pulmonary
ApplicantPulmonx Corporation
700 Chesapeake Drive
Redwood City, CA 94063
PMA NumberP180002
Date Received01/02/2018
Decision Date06/29/2018
Product Code NJK 
Docket Number 18M-2571
Notice Date 06/29/2018
Advisory Committee Anesthesiology
Clinical TrialsNCT00129584
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 S003 S009 S010 S004 S005 S014 S022 S025 S026 S001  
S006 S007 S011 S012 S013 S016 S017 S015 S008 S019 S020 S027 
S028 S029 S024 
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