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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.
 
DeviceZephyr Endobronchial Valve (Zephyr Valve)
Generic NameValve, pulmonary
ApplicantPulmonx Corporation
700 Chesapeake Dr.
Redwood City, CA 94063
PMA NumberP180002
Supplement NumberS019
Date Received07/16/2021
Decision Date08/13/2021
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 modifications to the protocol to include collection of perfusion data at baseline, extension of high-resolution computed tomography (HRCT) baseline data collection window from 3 months to 6 months prior to Informed Consent date, and collection of HRCT data at 12 months.
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