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 spiration® valve system. The spiration® valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have low collateral ventilation.
| Device | Spiration® Valve System |
| Classification Name | Valve, Pulmonary |
| Generic Name | Valve, Pulmonary |
| Applicant | Spiration, Inc. |
| Date Received | 2018-02-05 |
| Decision Date | 2018-12-03 |
| Notice Date | 2018-12-17 |
| PMA | P180007 |
| Supplement | S |
| Product Code | NJK |
| Docket Number | 18M-4665 |
| Advisory Committee | Anesthesiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Spiration, Inc. 6675 185th Avenue Ne redmond, WA 98052 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180007 | Original Filing | |
| S009 | 2022-04-12 | 30-day Notice |
| S008 | 2021-04-30 | Normal 180 Day Track No User Fee |
| S007 | 2020-10-21 | Normal 180 Day Track No User Fee |
| S006 | ||
| S005 | 2019-11-18 | Normal 180 Day Track |
| S004 | ||
| S003 | 2018-12-26 | Normal 180 Day Track No User Fee |
| S002 | 2018-12-26 | Normal 180 Day Track No User Fee |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00896506002323 | P180007 | 000 |
| 00896506002316 | P180007 | 000 |
| 00896506002309 | P180007 | 000 |
| 00896506002293 | P180007 | 000 |
| 00896506002286 | P180007 | 000 |
| 00896506002279 | P180007 | 000 |