| 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 Code | OOY |
|---|
| Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
