This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval of the pulmonx zephyr® endobronchial valve system. The device is an implantable bronchial valve 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 | Zephyr Endobronchial Valve System |
| Classification Name | Valve, Pulmonary |
| Generic Name | Valve, Pulmonary |
| Applicant | Pulmonx Corporation |
| Date Received | 2018-01-02 |
| Decision Date | 2018-06-29 |
| Notice Date | 2018-06-29 |
| PMA | P180002 |
| Supplement | S |
| Product Code | NJK |
| Docket Number | 18M-2571 |
| Advisory Committee | Anesthesiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Pulmonx Corporation 700 Chesapeake Drive redwood City, CA 94063 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00811907030720 | P180002 | 000 |
| 00811907030621 | P180002 | 000 |
| 00811907030522 | P180002 | 000 |
| 00811907030324 | P180002 | 000 |
| 00811907030225 | P180002 | 000 |
| 00811907030126 | P180002 | 000 |
| 00811907031222 | P180002 | 005 |
| 00811907030423 | P180002 | 005 |