OOY

Bronchial Thermoplasty System

Product code: OOY
Device name: Bronchial Thermoplasty System
Device class: Class 3
Medical specialty: Unknown
Marketing pathway: PMA

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: OOY

Classification and pathway per current FDA publications. Data from openFDA (CC0).