PMA P180002S020

Device
Zephyr Valve Registry (ZEVR)
Applicant
Pulmonx Corporation
PMA number
P180002
Supplement
S020
Product code
NJK
Decision date
2022-03-09
Generic name
Valve, pulmonary
Approval order statement
Approval for revising the study timeline due to COVID-19 pandemic delays

Current openFDA PMA Record#

Device
Zephyr Valve Registry (ZEVR)
Applicant
Pulmonx Corporation
PMA number
P180002
Supplement
S020
Product code
NJK
Generic name
Valve, pulmonary
Decision date
2022-03-09
Decision code
APPR
Date received
2022-02-07
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval for revising the study timeline due to COVID-19 pandemic delays