PMA P180002S007
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- Product code
- NJK
- Decision date
- 2019-08-01
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval to implement a revised process for the lot release testing sampling plan for Zephyr Endobronchial Valve System products.
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S007
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-08-01
- Decision code
- APPR
- Date received
- 2019-02-28
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement a revised process for the lot release testing sampling plan for Zephyr Endobronchial Valve System products.