PMA P180002S005
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- Product code
- NJK
- Decision date
- 2019-07-30
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for the Zephyr 5.5-LP Endobronchial Valve (EBV) and the Zephyr 5.5 Dual Mark Endobronchial Delivery Catheter (EDC).
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S005
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-07-30
- Decision code
- APPR
- Date received
- 2018-12-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Zephyr 5.5-LP Endobronchial Valve (EBV) and the Zephyr 5.5 Dual Mark Endobronchial Delivery Catheter (EDC).