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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
Classification Namevalve, pulmonary
Generic Namevalve, pulmonary
Applicant
Pulmonx Corporation
700 chesapeake drive
redwood city, CA 94063
PMA NumberP180002
Supplement NumberS005
Date Received12/17/2018
Decision Date07/30/2019
Product Code
NJK[ Registered Establishments with NJK ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Zephyr 5.5-LP Endobronchial Valve (EBV) and the Zephyr 5.5 Dual Mark Endobronchial Delivery Catheter (EDC).
Post-Approval StudyShow Report Schedule and Study Progress
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