BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ampere™ Generator Fiber Cord Assembly Remote

    Reg #: 3005334138 · FEI: 3005334138 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    2

    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
    P110016

    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 Flutter OAD
    Cardiac Ablation Percutaneous Catheter LPB

    Proprietary Names

    Ampere™ Generator Fiber Cord Assembly Remote Ampere™ Remote Control Ampere™ Generator Accessories Ampere Generator FlexAbility Ablation Catheter Therapy Cool Flex Ablation Catheter FlexAbility Ablation Catheter, Sensor Enabled Sensor Enabled™ Ablation Connection Cable IBI 1500T9-CP V1.6 Cardiac Ablation Generator Safire BLU Duo Ablation Catheter Therapy Cool Path Duo Ablation Catheter Ampere™ Footswitch Ampere™ Generator Kit

    Establishment Types

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