PMA P180002S011
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- Product code
- NJK
- Decision date
- 2019-12-23
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for including a smaller outer shipper box option which has the capacity for up to five (5) Zephyr Endobronchial Delivery Catheter (EDC) devices.
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S011
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-12-23
- Decision code
- APPR
- Date received
- 2019-09-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for including a smaller outer shipper box option which has the capacity for up to five (5) Zephyr Endobronchial Delivery Catheter (EDC) devices.