Zephyr Endobronchial Valve System
FDA premarket approval P180002 · decided 2018-06-29
Approval details
- PMA number
- P180002
- Trade name
- Zephyr Endobronchial Valve System
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2018-01-02
- Decision date
- 2018-06-29
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval of the Pulmonx Zephyr® Endobronchial Valve System. The device is an implantable bronchial valve 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 |