Premarket Approval (PMA)

Note: 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.

• Device: Alair Bronchial Thermoplasty System
• Generic Name: Bronchial thermoplasty system
• Applicant: Boston Scientific Corp; 888 Ross Dr.; Suite100; Sunnyvale, CA 94089
• PMA Number: P080032
• Supplement Number: S018
• Date Received: 04/30/2021
• Decision Date: 05/27/2021
• Product Code: OOY
• Advisory Committee: Anesthesiology
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Replacing components of an extrusion line.