BEUDAMED
    FDA Registration Active 🇺🇸 United States

    nGEN Generator

    Reg #: 3013300026 · FEI: 3013300026 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    BIOSENSE WEBSTER, INC.
    Registration Number
    3013300026
    FEI Number
    3013300026
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    PMA Number
    P950005

    Owner / Operator

    Firm Name
    BIOSENSE WEBSTER, INC.
    Operator Number
    9044811
    Address
    31 Technology Drive, Suite 200, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Maria Jose Arana

    Products

    Device Name Product Code
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Cardiac Ablation Percutaneous Catheter LPB

    Proprietary Names

    nGEN Generator Celsius Catheter EZ Steer Catheter Celsius RMT Catheter

    Establishment Types

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