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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 (EBV) System
Generic NameValve, pulmonary
ApplicantPulmonx Corporation
700 Chesapeake Dr.
Redwood City, CA 94063
PMA NumberP180002
Supplement NumberS028
Date Received07/26/2024
Decision Date08/23/2024
Product Code NJK 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
A manufacturing change from two cycles of ethylene oxide (EO) sterilization to three cycles of ethylene oxide sterilization with a three-year shelf life for two lots of the Zephyr 4.0-LP EBV (Lot 506377-V7.1 and Lot 506412-V7.1).
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