PMA P180002S029

Device: Zephyr Endobronchial Valve System
Applicant: Pulmonx Corporation
PMA number: P180002
Supplement: S029
Product code: NJK
Decision date: 2024-12-04
Classification: Anesthesiology
Generic name: Valve, pulmonary
Approval order statement: Approval for the change of using a modified funnel component for the Endobronchial Loader System included with the Zephyr 4.0 and 5.5-LP Endobronchial Valve (EBV) product models

Current openFDA PMA Record#

Device: Zephyr Endobronchial Valve System
Applicant: Pulmonx Corporation
PMA number: P180002
Supplement: S029
Product code: NJK
Generic name: Valve, pulmonary
Decision date: 2024-12-04
Decision code: APPR
Date received: 2024-09-03
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the change of using a modified funnel component for the Endobronchial Loader System included with the Zephyr 4.0 and 5.5-LP Endobronchial Valve (EBV) product models