Zephyr Endobronchial Valve (EBV) System
FDA premarket approval P180002/S001 · decided 2018-10-25
Approval details
- PMA number
- P180002
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zephyr Endobronchial Valve (EBV) System
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2018-07-09
- Decision date
- 2018-10-25
- Days to decision
- 108 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval for the proposed design changes to the funnel of the Endobronchial Loader System that is included with the Zephyr 5.5 Endobronchial valve model.
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