PMA P180002S001

Device
Zephyr Endobronchial Valve (EBV) System
Applicant
Pulmonx Corporation
PMA number
P180002
Supplement
S001
Product code
NJK
Decision date
2018-10-25
Classification
Valve, Pulmonary
Generic name
Valve, pulmonary
Approval order statement
Approval for the proposed design changes to the funnel of the Endobronchial Loader System that is included with the Zephyr 5.5 Endobronchial valve model.
Summary
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Current openFDA PMA Record#

Device
Zephyr Endobronchial Valve (EBV) System
Applicant
Pulmonx Corporation
PMA number
P180002
Supplement
S001
Product code
NJK
Generic name
Valve, pulmonary
Decision date
2018-10-25
Decision code
APPR
Date received
2018-07-09
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the proposed design changes to the funnel of the Endobronchial Loader System that is included with the Zephyr 5.5 Endobronchial valve model.