PMA P180002S016
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S016
- Product code
- NJK
- Decision date
- 2020-10-30
- Generic name
- Valve, pulmonary
- Approval order statement
- Modify the manufacturing process of laminating the inner shaft for Endobronchial Delivery Catheters (EDCs).
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve (EBV) System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S016
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2020-10-30
- Decision code
- OK30
- Date received
- 2020-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the manufacturing process of laminating the inner shaft for Endobronchial Delivery Catheters (EDCs).