PMA P180002S032

Device
Zephyr Endobronchial Valve System
Applicant
Pulmonx Corporation
PMA number
P180002
Supplement
S032
Product code
NJK
Decision date
2026-09-11
Classification
Anesthesiology
Generic name
Valve, pulmonary
Approval order statement
Approval for changes to the funnel component of the Endobronchial Loader System included with the Zephyr 4.0-LP Endobronchial Valve.

Current openFDA PMA Record#

Device
Zephyr Endobronchial Valve System
Applicant
Pulmonx Corporation
PMA number
P180002
Supplement
S032
Product code
NJK
Generic name
Valve, pulmonary
Decision date
2026-09-11
Decision code
APPR
Date received
2026-07-01
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to the funnel component of the Endobronchial Loader System included with the Zephyr 4.0-LP Endobronchial Valve.