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    FDA Registration Active 🇺🇸 United States

    TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-J

    Reg #: 3005334138 · FEI: 3005334138 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    3
    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

    Regulatory Submissions

    PMA Number
    P220013

    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
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

    Proprietary Names

    TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-J TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-FF TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-FJ TactiSys™ Quartz, TactiFlex™ Radiofrequency Cable, TSQ-RF-TFSE-CBL TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-JJ TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-F TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-DF TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-D TactiFlex™ Sensor Enabled™ Ablation Catheter - A-TFSE-DD Ampere™ Generator Ampere™ Generator Kit Ampere™ Remote Control

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device