BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EnSite™ X EP System Contact Force Software License, ENSITE-D-CFLF-01

    Reg #: 3005334138 · FEI: 3005334138 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    29
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    St. Jude Medical, Cardiology Division, Inc.
    Registration Number
    3005334138
    FEI Number
    3005334138
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5050 Nathan Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55442
    Country
    US

    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
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    EnSite™ X EP System Contact Force Software License, ENSITE-D-CFLF-01 EnSite™ X EP System Radio-lucent ECG Lead Set, ENSITE-ECGRL-I-01 RecordConnect (Universal Refurb) - 100040093 EnSite™ X EP System SurfaceLink Module, ENSITE-SRFLNK-I-01 EnSite™ Velocity™ Ablation Cable Kit, Stockert - 75-04469-003 Power Kit OUS-H702505 Ensite Velocity Intl Power Kit - 100019046 EnSite Precision™ Module - Hardware- H702473 EnSite™ Velocity™ Amplifier Cart - H710002 EnSite™ System (RFB GenConnect interface to Atakr™ generator) - 100039379 Recorder Interconnect Kit, Bard V5 - 75-04629-002 EnSite™ X EP System ECG Output Module, ENSITE-ECGOUT-I-01 EnSite™ X EP System Radio-opaque ECG Lead Set, ENSITE-ECGRO-I-01 EnSite™ X EP System Contact Force Software License, ENSITE-CFLF-01 TactiCath™ Ablation Catheter, Sensor Enabled™, Software Installation, 30 Day Trial - H702517-T EnSite™ System GenConnect (GenConnect interface to EPT™ generator) - 100038592 TactiCath™ Ablation Catheter, Sensor Enabled™, Catheter Catalog Installation, v.1 - H702518 EnSite™ Velocity™ Stockert GenConnect (Refurb) - 100047843 EnSite™ Verismo™, Software Installation, v.2.x - H00001 EnSite™ Velocity™ Ablation Cable Kit, IFI, T9 - 75-05392-001 Bedrail Clamp- 100007639 EnSite™ X EP System TactiFlex™ Ablation Catheter Sensor Enabled™ Software Upgrade, ENSITE-TFM-01 EnSite™ X EP System TactiFlex™ Ablation Catheter Sensor Enabled™ Software License, ENSITE-TF-01 ENSITE-GENECG-OUS EnSite™ X EP System PFA ECG Signal Splitter EnSite™ X EP System, AutoMark Index Software License, ENSITE-AMI-01 WorkMate™ Scribe™ Module EnSite™ X EP System, AutoMark Index Temporary Software License, ENSITE-D-AMI-01 WorkMate Claris™ System, Power Kit, China WorkMate Claris™ System

    Establishment Types

    Manufacture Device in the United States for Export Only