BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bronchial Thermoplasty System

    PMA: P080032 · Supplement: S017 · Decision Oct 5, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Bronchial Thermoplasty System
    Trade Name
    Alair Bronchial Thermoplasty Catheter
    PMA Number
    P080032
    Supplement Number
    S017
    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
    October 5, 2018
    Date Received
    November 29, 2017
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for revising the manufacturing procedure for the Alair Bronchial Thermoplasty Catheter by allowing rework of the polyester heat shrink insulation placed over the electrodes if inspection criteria are not met.

    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