BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bronchial Thermoplasty System

    PMA: P080032 · Decision Apr 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Bronchial Thermoplasty System
    Trade Name
    ALAIR BRONCHIAL THERMOPLASTY SYSTEM
    PMA Number
    P080032
    Device Class
    FDA Class 3
    Product Code
    OOY
    Generic Name
    Bronchial thermoplasty system
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 27, 2010
    Date Received
    December 30, 2008
    Expedited Review
    Y
    Docket Number
    10M-0242

    Advisory Committee Statement

    APPROVAL FOR THE ALAIR BRONCHIAL THERMOPLASTY SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF SEVERE PERSISTENT ASTHMA IN PATIENT 18 YEARS AND OLDER WHOSE ASTHMA IS NOT WELL CONTROLLED WITH INHALED CORTICOSTEROIDS AND LONG ACTING BETA AGONISTS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OOY Bronchial Thermoplasty System