PMA P180002S008
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S008
- Product code
- NJK
- Decision date
- 2019-07-17
- Classification
- Valve, Pulmonary
- Generic name
- Valve, pulmonary
- Approval order statement
- Addition of an alternate supplier of the funnel component of the Endobronchial Loader System (ELS).
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S008
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-07-17
- Decision code
- OK30
- Date received
- 2019-06-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier of the funnel component of the Endobronchial Loader System (ELS).