BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bronchial Thermoplasty System

    PMA: P080032 · Supplement: S010 · Decision Nov 9, 2012
    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
    Supplement Number
    S010
    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
    November 9, 2012
    Date Received
    October 11, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES TO THE ALAIR CATHETER MODEL ATS 2-5 DIRECTIONS FOR USE (DFU), ALAIR RADIOFREQUENCY (RF) CONTROLLER MODEL ATS 200 OPERATOR'S MANUAL, AND ALAIR BRONCHIAL THERMOPLASTY SYSTEM PATIENT BROCHURE.

    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