PMA P180002S004
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S004
- Product code
- NJK
- Decision date
- 2019-01-28
- Classification
- Valve, Pulmonary
- Generic name
- Valve, pulmonary
- Approval order statement
- Approval for a waiver of the 6-month Post Approval Study (PAS) reporting requirement for the LIBERATE extension study.
Current openFDA PMA Record#
- Device
- Zephyr Endobronchial Valve System
- Applicant
- Pulmonx Corporation
- PMA number
- P180002
- Supplement
- S004
- Product code
- NJK
- Generic name
- Valve, pulmonary
- Decision date
- 2019-01-28
- Decision code
- APPR
- Date received
- 2018-11-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for a waiver of the 6-month Post Approval Study (PAS) reporting requirement for the LIBERATE extension study.