Zephyr Endobronchial Valve System
FDA premarket approval P180002/S004 · decided 2019-01-28
Approval details
- PMA number
- P180002
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Zephyr Endobronchial Valve System
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2018-11-29
- Decision date
- 2019-01-28
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for a waiver of the 6-month Post Approval Study (PAS) reporting requirement for the LIBERATE extension study.
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510(k) clearances by this applicant
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|---|---|---|
| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
| Chartis Precision Catheter (K222340) | Pulmonx Corporation | 2022-12-01 |
| Lung Image Analysis (K212494) | Pulmonx Corporation | 2021-09-02 |
| Pulmonx Chartis Tablet Console (K180011) | Pulmonx Corporation | 2018-07-13 |