ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Bronchial Thermoplasty System

FDA Premarket Approval P080032 S012

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 1) the manufacturing transfer of the alair catheter from the current facility in sunnyvale, california, to the boston scientific facility in cork, ireland; and 2) the qualification of synergy health ireland ltd, located in tullamore, ireland, as a sterilization site for the alair catheter, and minor design changes to the alair catheter. Approval for 1) the manufacturing transfer of the alair catheter from the current facility in sunnyvale, california, to the boston scientific facility in cork, ireland; and 2) the qualification of synergy health ireland ltd, located in tullamore, ireland, as a sterilization site for the alair catheter, and minor design changes to the alair catheter.

• Device: ALAIR BRONCHIAL THERMOPLASTY SYSTEM
• Classification Name: Bronchial Thermoplasty System
• Generic Name: Bronchial Thermoplasty System
• Applicant: Boston Scientific Corp.
• Date Received: 2012-12-26
• Decision Date: 2013-07-03
• PMA: P080032
• Supplement: S012
• Product Code: OOY
• Advisory Committee: Anesthesiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• 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