Approval for the pulmonx zephyr® endobronchial valves are implantable bronchial valves 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.
| Device | Pulmonx Zephyr Endobronchial Valve (EBV) |
| Classification Name | Valve, Pulmonary |
| Generic Name | Valve, Pulmonary |
| Applicant | Pulmonx Corporation |
| Date Received | 2018-07-27 |
| Decision Date | 2018-09-25 |
| PMA | P180002 |
| Supplement | S002 |
| Product Code | NJK |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Pulmonx Corporation 700 Chesapeake Drive redwood City, CA 94063 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180002 | | Original Filing |
| S020 |
2022-02-07 |
Normal 180 Day Track No User Fee |
| S019 |
2021-07-16 |
Normal 180 Day Track No User Fee |
| S018 | | |
| S017 |
2020-10-23 |
30-day Notice |
| S016 |
2020-09-30 |
30-day Notice |
| S015 |
2019-12-19 |
135 Review Track For 30-day Notice |
| S014 |
2019-11-08 |
30-day Notice |
| S013 |
2019-10-25 |
30-day Notice |
| S012 |
2019-10-24 |
30-day Notice |
| S011 | | |
| S010 |
2019-08-19 |
Real-time Process |
| S009 |
2019-08-05 |
Normal 180 Day Track No User Fee |
| S008 |
2019-06-17 |
30-day Notice |
| S007 | | |
| S006 |
2019-02-15 |
135 Review Track For 30-day Notice |
| S005 | | |
| S004 |
2018-11-29 |
Normal 180 Day Track No User Fee |
| S003 | | |
| S002 |
2018-07-27 |
Normal 180 Day Track No User Fee |
| S001 |
2018-07-09 |
Real-time Process |
NIH GUDID Devices