Alair Bronchial Thermoplasty System

FDA Premarket Approval P080032 S018

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.

Pre-market Approval Supplement Details

Approval for replacing components of an extrusion line.

DeviceAlair Bronchial Thermoplasty System
Generic NameBronchial Thermoplasty System
ApplicantBoston Scientific Corp.
Date Received2021-04-30
Decision Date2021-05-27
PMAP080032
SupplementS018
Product CodeOOY 
Advisory CommitteeAnesthesiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Boston Scientific Corp. 888 Ross Drive suite 100 sunnyvale, CA 94089

Supplemental Filings

Supplement NumberDateSupplement Type
P080032Original Filing
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

Device IDPMASupp
08714729802822 P080032 000
08714729802792 P080032 000
08714729802778 P080032 000
08714729796695 P080032 000
08714729961154 P080032 016

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.