Approval for labeling changes to the alair catheter model ats 2-5 directions for use (dfu), alair radiofrequency (rf) controller model ats 200 operator's manual, and alair bronchial thermoplasty system patient brochure.
| Device | ALAIR BRONCHIAL THERMOPLASTY SYSTEM |
| Classification Name | Bronchial Thermoplasty System |
| Generic Name | Bronchial Thermoplasty System |
| Applicant | Boston Scientific Corp. |
| Date Received | 2012-10-11 |
| Decision Date | 2012-11-09 |
| PMA | P080032 |
| Supplement | S010 |
| Product Code | OOY |
| Advisory Committee | Anesthesiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 888 Ross Drive suite 100 sunnyvale, CA 94089 |
Supplemental Filings
| 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 | | |
NIH GUDID Devices