Approval for modifications to your protocol to include collection of perfusion data at baseline, extension of high-resolution computed tomography (hrct) baseline data collection window from 3 months to 6 months prior to informed consent date, and collection of hrct data at 12 months
| Device | Zephyr Endobronchial Valve (Zephyr Valve) |
| Generic Name | Valve, Pulmonary |
| Applicant | Pulmonx Corporation |
| Date Received | 2021-07-16 |
| Decision Date | 2021-08-13 |
| PMA | P180002 |
| Supplement | S019 |
| Product Code | NJK |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| 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