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.

• Device: Alair Bronchial Thermoplasty System
• Generic Name: Bronchial Thermoplasty System
• Applicant: Boston Scientific Corp.
• Date Received: 2021-04-30
• Decision Date: 2021-05-27
• PMA: P080032
• Supplement: S018
• 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

Device ID	PMA	Supp
08714729802822	P080032	000
08714729802792	P080032	000
08714729802778	P080032	000
08714729796695	P080032	000
08714729961154	P080032	016