BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PressureWire Aeris / Certus (Gen 8)

    Reg #: 2184149 · FEI: 1000139754 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    St. Jude Medical, Atrial Fibrillation Division, Inc.
    Registration Number
    2184149
    FEI Number
    1000139754
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    One St. Jude Medical Drive
    City
    Saint Paul
    State
    MN
    ZIP
    55117
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140466

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Wire, Guide, Catheter DQX
    Transmitters And Receivers, Physiological Signal, Radiofrequency DRG
    Transducer, Pressure, Catheter Tip DXO

    Proprietary Names

    PressureWire Aeris / Certus (Gen 8)

    Establishment Types

    Manufacture Medical Device