Alair Bronchial Thermoplasty Catheter

Bronchial Thermoplasty System

FDA Premarket Approval P080032 S017

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 revising the manufacturing procedure for the alair bronchial thermoplasty catheter by allowing rework of the polyester heat shrink insulation placed over the electrodes if inspection criteria are not met.

• Device: Alair Bronchial Thermoplasty Catheter
• Classification Name: Bronchial Thermoplasty System
• Generic Name: Bronchial Thermoplasty System
• Applicant: Boston Scientific Corp.
• Date Received: 2017-11-29
• Decision Date: 2018-10-05
• PMA: P080032
• Supplement: S017
• Product Code: OOY
• Docket Number: Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia
• Advisory Committee: Anesthesiology
• Supplement Type: 135 Review Track For 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