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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 Valve Registry (ZEVR)
Generic NameValve, pulmonary
ApplicantPulmonx Corporation
700 Chesapeake Drive
Redwood City, CA 94063
PMA NumberP180002
Supplement NumberS020
Date Received02/07/2022
Decision Date03/09/2022
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
Approval Order Statement  
Approval for revising the study timeline due to COVID-19 pandemic delays
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