Bronchial Thermoplasty System
FDA product code OOY · Class III (high risk) · Anesthesiology
Bronchial thermoplasty systems are intended for the treatment of severe persistent asthma in patients whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists to reduce the effects of their asthma by using thermal radiofrequency energy to ablate smooth muscle tissue in the patient's airways.
0510(k) clearances
1PMA approvals
1recalls
PMA approvals
- P080032 Alair Bronchial Thermoplasty System · Boston Scientific Corp · 04/27/2010
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1748-2013 Class II | Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number:…Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair… | Boston Scientific Corporation | 05/28/2013Terminated |