Zephyr Endobronchial Valve (EBV) System
FDA premarket approval P180002/S007 · decided 2019-08-01
Approval details
- PMA number
- P180002
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zephyr Endobronchial Valve (EBV) System
- Generic name
- Valve, pulmonary
- Applicant
- Pulmonx Corporation
- Date received
- 2019-02-28
- Decision date
- 2019-08-01
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- NJK
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Redwood City, CA
- Statement
- Approval to implement a revised process for the lot release testing sampling plan for Zephyr Endobronchial Valve System products.
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