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 for the alair bronchial thermoplasty system. The device is indicated for the treatment of severe persistent asthma in patient 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
| Device | ALAIR BRONCHIAL THERMOPLASTY SYSTEM |
| Classification Name | Bronchial Thermoplasty System |
| Generic Name | Bronchial Thermoplasty System |
| Applicant | Boston Scientific Corp. |
| Date Received | 2008-12-30 |
| Decision Date | 2010-04-27 |
| Notice Date | 2010-05-19 |
| PMA | P080032 |
| Supplement | S |
| Product Code | OOY |
| Docket Number | 10M-0242 |
| Advisory Committee | Anesthesiology |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 888 Ross Drive suite 100 sunnyvale, CA 94089 |
| 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 |
|---|---|---|
| P080032 | Original Filing | |
| S020 | 2021-10-28 | 30-day Notice |
| S019 | ||
| S018 | 2021-04-30 | 30-day Notice |
| S017 | 2017-11-29 | 135 Review Track For 30-day Notice |
| S016 | 2015-06-01 | Normal 180 Day Track |
| S015 | 2014-03-14 | Normal 180 Day Track No User Fee |
| S014 | 2013-11-05 | 30-day Notice |
| S013 | 2013-03-14 | Normal 180 Day Track No User Fee |
| S012 | 2012-12-26 | Normal 180 Day Track |
| S011 | 2012-11-15 | 30-day Notice |
| S010 | 2012-10-11 | Special (immediate Track) |
| S009 | 2012-02-14 | Normal 180 Day Track No User Fee |
| S008 | 2012-02-21 | 30-day Notice |
| S007 | 2011-06-03 | Normal 180 Day Track No User Fee |
| S006 | 2011-02-11 | Normal 180 Day Track No User Fee |
| S005 | 2010-11-08 | Normal 180 Day Track No User Fee |
| S004 | 2010-08-13 | Normal 180 Day Track |
| S003 | 2010-08-02 | 30-day Notice |
| S002 | 2010-05-28 | Normal 180 Day Track No User Fee |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 08714729802822 | P080032 | 000 |
| 08714729802792 | P080032 | 000 |
| 08714729802778 | P080032 | 000 |
| 08714729796695 | P080032 | 000 |
| 08714729961154 | P080032 | 016 |