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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceThe Pulmonx Zephyr Endobronchial Valve System (EBV)
Generic NameValve, pulmonary
ApplicantPulmonx Corporation
700 Chesapeake Dr.
Redwood City, CA 94063
PMA NumberP180002
Supplement NumberS003
Date Received07/30/2018
Decision Date05/03/2019
Product Code NJK 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the Pulmonx Zephyr® Endobronchial Valves. These are implantable bronchial valves which are 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.
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