Bronchial Thermoplasty System

Product Code: OOY

Microwave Medical Products

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.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations:


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as OOY

231Bronchial Thermoplasty System

Total Product Life Cycle (TPLC) Devices

231Bronchial Thermoplasty System

Pre-market Approvals for OOY

P080032Alair Bronchial Thermoplasty CatheterBoston Scientific Corp.

Global Unique Device Identification Database

08714729961154Bronchial thermoplasty system
08714729802822Bronchial thermoplasty system
08714729802792Bronchial thermoplasty system
08714729802778Bronchial thermoplasty system
08714729796695Bronchial thermoplasty system

Maude Adverse Events

ALAIRBOSTON SCIENTIFIC CORPORATION2020-03-23
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ALAIRBOSTON SCIENTIFIC CORPORATION2019-09-25
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ALAIRBOSTON SCIENTIFIC CORPORATION2019-08-21
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