BEUDAMED
    FDA Registration Active 🇺🇸 United States

    DiamondTemp™ Ablation Catheter

    Reg #: 2182208 · FEI: 2182208 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDTRONIC, INC.
    Registration Number
    2182208
    FEI Number
    2182208
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8200 Coral Sea Street NE
    City
    Mounds View
    State
    MN
    ZIP
    55112
    Country
    US

    Regulatory Submissions

    PMA Number
    P200028

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

    Device Name Product Code
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

    Proprietary Names

    DiamondTemp™ Ablation Catheter DiamondTemp™ EGM Cable DiamondTemp Ablation System DiamondTemp™ Irrigation Pump DiamondTemp™ Catheter-to-RF Generator Cable DiamondTemp™ Generator Connection Box E DiamondTemp™ RF Generator DiamondTemp™ Irrigation Tubing Set DiamondTemp™ GenConnect Cable DiamondTemp™ Foot Switch

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility