BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INTELLAGEN RF Generator Kit

    Reg #: 3010705768 · FEI: 3010705768 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    38
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Boston Scientific Corporation
    Registration Number
    3010705768
    FEI Number
    3010705768
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    309 Waverley Oaks Rd.
    City
    Waltham
    State
    MA
    ZIP
    02452
    Country
    US

    Regulatory Submissions

    PMA Number
    P150005

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

    Proprietary Names

    INTELLAGEN RF Generator Kit INTELLAGEN Remote Control Kit INTELLAGEN Remote Control Connection Cable 15 Meter IntellaNav Open-Irrigated Ablation Catheter MetriQ Pump Irrigation Pump MetriQ Foot Switch Blazer Open-Irrigated Ablation Catheter Cable, Maestro 4000 IntellaTip MiFi Open-Irrigated Ablation Catheter MetriQ Irrigation Tubing Set Open-Irrigation Tubing Set Rhythmia Mapping System IntellaNav CB - Maestro IntellaNav MiFi Open-Irrigated Ablation Catheter Rhythmia HDx Ablation Connection Box Maestro INTELLAGEN Irrigation Pump Connection Cable 3 Meter INTELLAGEN Irrigation Pump Connection Cable 1 Meter INTELLAGEN ECG Connection Cable 3 Meter Rhythmia HDx Ablation Connection Box - IntellaNav StablePoint - for INTELLAGEN Cable, IntellaNav Ablation Catheter IntellaNav StablePoint Catheter Cable INTELLAGEN Serial Communication Cable 15 Meter INTELLAGEN Serial Communication Cable 3 Meter INTELLAGEN Catheter Adapter Cable 0.3 Meter INTELLAGEN Foot Pedal Cable IntellaTip MiFi OI to Maestro 4000 INTELLAGEN Irrigation Pump Kit INTELLAGEN Tubing Set INTELLAGEN Irrigation Pump Connection Cable 5 Meter INTELLAGEN Remote Control Connection Cable 10 Meter Rhythmia HDx Ablation Connection Box - for INTELLAGEN INTELLAGEN Irrigation Pump Connection Cable 10 Meter INTELLAGEN Remote Control Connection Cable 30 Meter INTELLAGEN Grounding Cable 3 Meter INTELLAGEN Remote Control Connection Cable 25 Meter RHYTHMIA HDx Ablation Connection Box – IntellaNav StablePoint IntellaNav StablePoint Ablation Catheter Cable, IntellaTip MiFi OI INTELLAGEN Serial Communication Cable 5 Meter INTELLAGEN Foot Pedal Extension Cable 7 Meter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility