BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LivaNova USA, Inc.

    Reg #: 1644487 · FEI: 1000117004 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    LivaNova USA, Inc.
    Registration Number
    1644487
    FEI Number
    1000117004
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    100 CYBERONICS BLVD.
    City
    HOUSTON
    State
    TX
    ZIP
    77058
    Country
    US

    Regulatory Submissions

    510(k) Number
    K092364
    PMA Number
    P970003

    Owner / Operator

    Firm Name
    LivaNova USA, Inc.
    Operator Number
    9002738
    Address
    100 CYBERONICS BLVD., --
    City
    Houston
    State
    TX
    Postal Code
    77058
    Country
    US
    Correspondent
    Bijal Patel-Jain

    Products

    Device Name Product Code
    Stimulator, Autonomic Nerve, Implanted For Epilepsy LYJ
    Stimulator, Autonomic Nerve, Implanted (Depression) MUZ
    Instrument, Surgical, Non-Powered HAO
    Magnet, Test, Pacemaker DTG

    Proprietary Names

    VAGUS NERVE STIMULATOR (VNS) SYSTEM VNS THERAPY MODEL 402 TUNNELER Model 220, Patient Magnet

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device