BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Bronchial Thermoplasty System

    PMA: P080032 · Supplement: S014 · Decision Dec 2, 2013
    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
    S014
    Device Class
    FDA Class 3
    Product Code
    OOY
    Generic Name
    Bronchial thermoplasty system
    Medical Specialty
    Unknown
    Advisory Committee
    Anesthesiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 2, 2013
    Date Received
    November 5, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO THE MANUFACTURING OF A CABLE CONNECTOR, THE ADDITION OF ANINSPECTION STEP AND THE ELIMINATION OF A FINAL ACCEPTANCE ACTIVITY.

    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