FDA.reportPublic FDA data

PMA P180002S002

Device
Pulmonx Zephyr Endobronchial Valve (EBV)
Applicant
Pulmonx Corporation
PMA number
P180002
Supplement
S002
Product code
NJK
Decision date
2018-09-25
Classification
Valve, Pulmonary
Generic name
Valve, pulmonary
Approval order statement
Approval for The Pulmonx Zephyr® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation.

Current openFDA PMA Record#

Device
Pulmonx Zephyr Endobronchial Valve (EBV)
Applicant
Pulmonx Corporation
PMA number
P180002
Supplement
S002
Product code
NJK
Generic name
Valve, pulmonary
Decision date
2018-09-25
Decision code
APPR
Date received
2018-07-27
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval for The Pulmonx Zephyr® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation.