OOY — Bronchial Thermoplasty System Class III
FDA product code OOY covers "Bronchial Thermoplasty System", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- OOY
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Unknown
- Implant
- No
Definition
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.