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 Therma
| Device Type ID | 231 |
| Device Name | Bronchial Thermoplasty System |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OOY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 231 |
| Device | Bronchial Thermoplasty System |
| Product Code | OOY |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 203 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 204 |