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Device | Zephyr Endobronchial Valve (EBV) System |
Generic Name | Valve, pulmonary |
Applicant | Pulmonx Corporation 700 Chesapeake Drive Redwood City, CA 94063 |
PMA Number | P180002 |
Supplement Number | S005 |
Date Received | 12/17/2018 |
Decision Date | 07/30/2019 |
Product Code |
NJK |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Zephyr 5.5-LP Endobronchial Valve (EBV) and the Zephyr 5.5 Dual Mark Endobronchial Delivery Catheter (EDC). |
Post-Approval Study | Show Report Schedule and Study Progress |