This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Zephyr Valve Registry (ZEVR) |
| Generic Name | Valve, Pulmonary |
| Applicant | Pulmonx Corporation700 Chesapeake Driveredwood City, CA 94063 PMA NumberP180002 Supplement NumberS020 Date Received02/07/2022 Decision Date03/09/2022 Product Code NJK Advisory Committee Anesthesiology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-02-07 |
| Decision Date | 2022-03-09 |
| PMA | P180002 |
| Supplement | S020 |
| 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 PMA NumberP180002 Supplement NumberS020 Date Received02/07/2022 Decision Date03/09/2022 Product Code NJK Advisory Committee Anesthesiology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement revising Your Study Timeline Due To COVID-19 Pandemic Delays |
| 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 |