BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bronchial Thermoplasty System

    PMA: P080032 · Supplement: S015 · Decision Jun 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Bronchial Thermoplasty System
    Trade Name
    ALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER
    PMA Number
    P080032
    Supplement Number
    S015
    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
    June 17, 2014
    Date Received
    March 14, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA.

    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