30-day notice to the rotablator rotational angioplasty system, rotapro rotational atherectomy system and the alair™ bronchial thermoplasty system is approved for the addition of automated ultrasonic cleaning equipment with forced air dryer at the supplier for components used in the rotalink and rotapro advancers and alair catheter for the bundled submission p900056/s195 and p080032/s020.
Device | Alair Bronchial Thermoplasty System |
Generic Name | Bronchial Thermoplasty System |
Applicant | Boston Scientific Corp. |
Date Received | 2021-10-28 |
Decision Date | 2021-11-26 |
PMA | P080032 |
Supplement | S020 |
Product Code | OOY |
Advisory Committee | Anesthesiology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
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