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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 NumberS014
Date Received11/08/2019
Decision Date12/06/2019
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  
Manufacturing change of adding the option of performing lot release testing of the Zephyr Endobronchial Delivery Catheter (EDC) before sterilization.
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