Pulmonx Zephyr Endobronchial Valve (EBV)
FDA premarket approval P180002/S002 · decided 2018-09-25
Approval details
- PMA number
- P180002
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Pulmonx Zephyr Endobronchial Valve (EBV)
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2018-07-27
- Decision date
- 2018-09-25
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for The Pulmonx Zephyr® Endobronchial Valves are implantable bronchial valves indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation.
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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 |