Premarket Approval (PMA)

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.

• Device: Zephyr Valve Reigstry (ZEVR)
• Generic Name: Valve, pulmonary
• Applicant: Pulmonx Corporation; 700 Chesapeake Dr.; Redwood City, CA 94063
• PMA Number: P180002
• Supplement Number: S022
• Date Received: 02/23/2023
• Decision Date: 03/25/2023
• Product Code: NJK
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for modifications to the protocol including an increase in study sites from 10 to 15 and minor clarification changes.