BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bronchial Thermoplasty System

    PMA: P080032 · Supplement: S004 · Decision Feb 4, 2011
    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
    S004
    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
    February 4, 2011
    Date Received
    August 13, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING GAMMA IRRADIATION AS AN ALTERNATIVE STERILIZATION METHOD, ESTABLISHING EXPIRATION DATING FOR THAT STERILIZATION METHOD, AND ADDING STERIGENICS (HAYWARD, CALIFORNIA) AS A CONTRACT STERILIZER.

    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