BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Alair Bronchial Thermoplasty Controller

    Reg #: 3005099803 · FEI: 3005099803 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BOSTON SCIENTIFIC CORPORATION
    Registration Number
    3005099803
    FEI Number
    3005099803
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 BOSTON SCIENTIFIC WAY
    City
    Marlborough
    State
    MA
    ZIP
    01752
    Country
    US

    Regulatory Submissions

    PMA Number
    P080032

    Owner / Operator

    Firm Name
    Boston Scientific Corporation
    Operator Number
    9912058
    Address
    300 Boston Scientific Way
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US

    Products

    Device Name Product Code
    Bronchial Thermoplasty System OOY

    Proprietary Names

    Alair Bronchial Thermoplasty Controller Alair RF Controller Accessory Kit Alair Bronchial Thermoplasty Catheter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198