The Pulmonx Zephyr Endobronchial Valve System (EBV)
FDA premarket approval P180002/S003 · decided 2019-05-03
Approval details
- PMA number
- P180002
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- The Pulmonx Zephyr Endobronchial Valve System (EBV)
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2018-07-30
- Decision date
- 2019-05-03
- Days to decision
- 277 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. These are implantable bronchial valves which are 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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| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
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