BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDTRONIC, INC.

    Reg #: 3012520654 · FEI: 3012520654 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    12
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    MEDTRONIC, INC.
    Registration Number
    3012520654
    FEI Number
    3012520654
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    880 Technology Park Drive
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233943
    PMA Number
    P240013

    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
    Computer, Diagnostic, Programmable DQK
    Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation QZI
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter OAD
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

    Proprietary Names

    Prism-1 Mapping System System Cart Location Reference Patch Sphere-9™ Catheter Affera™ Ablation System Affera™ Mapping System Location Reference Patch Kit HexaFlow™ Irrigation Pump Catheter Extension Cable HexaGen™ RF Generator HexaPulse™ PF Generator Tubing Set

    Establishment Types

    Manufacture Device in the United States for Export Only Manufacture Medical Device