• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
New Search Back to Search Results
Device bronchial thermoplasty system
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.
Physical State Bronchial thermoplasty systems are composed of a catheter with an electrode that delivers radiofrequency (RF) energy to the airways, as well as an controller unit that generates RF energy and controls the parameters of delivery.
Technical Method Bronchial thermoplasty systems use radiofrequency (RF) energy to ablate smooth muscle tissue in the airways.
Target Area Bronchial thermoplasty systems target the airways of the lung and the smooth muscle that lines the airway lumen.
Review Panel Anesthesiology
Product CodeOOY
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible