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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeOOY
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
2 1 0 0 0 0

MDR Year MDR Reports MDR Events
2022 5 5
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Alarm System 4 4
Activation Problem 2 2
Material Integrity Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Burn(s) 1 1
Necrosis 1 1
Pain 1 1
Respiratory Insufficiency 1 1
Swelling/ Edema 1 1

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