Last synced on 12 August 2022 at 11:05 pm

Bronchial Thermoplasty System

Page Type
Product Code
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
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code OOY to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.

Bronchial Thermoplasty System

Page Type
Product Code
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
Submission Type
PMA
Device Classification
Class 3
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

The FDA has not linked product code OOY to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:

  • The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
  • The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
  • The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.