PMA P180002S006
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S006
- Product code
- NJK
- Decision date
- 2019-07-19
- Classification
- Valve, Pulmonary
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval to use an alternate supplier, Laserage (Waukegan, IL), for the retainer component of the Zephyr 4.0 Endobronchial Valve.
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S006
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-07-19
- Decision code
- APPR
- Date received
- 2019-02-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to use an alternate supplier, Laserage (Waukegan, IL), for the retainer component of the Zephyr 4.0 Endobronchial Valve.