Alair Bronchial Thermoplasty System
FDA premarket approval P080032 · Bronchial thermoplasty system
PMA numberP080032
Approval
- Applicant
- Boston Scientific Corp
- Received
- December 30, 2008
- Decision date
- April 27, 2010 (APPR)
- Supplements
- 20, latest February 18, 2022
- Product code
- OOY – Bronchial Thermoplasty System
Approval order statement
APPROVAL FOR THE ALAIR BRONCHIAL THERMOPLASTY SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF SEVERE PERSISTENT ASTHMA IN PATIENT 18 YEARS AND OLDER WHOSE ASTHMA IS NOT WELL CONTROLLED WITH INHALED CORTICOSTEROIDS AND LONG ACTING BETA AGONISTS.