BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Model 3028 MR Conditional Implantable Pulse Generator

    Reg #: 3007666314 · FEI: 3007666314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    INSPIRE MEDICAL SYSTEMS INC
    Registration Number
    3007666314
    FEI Number
    3007666314
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5500 Wayzata Blvd. Suite 1600
    City
    Golden Valley
    State
    MN
    ZIP
    55416
    Country
    US

    Regulatory Submissions

    PMA Number
    P130008

    Owner / Operator

    Firm Name
    Inspire Medical Systems Inc.
    Operator Number
    10046749
    Address
    5500 Wayzata Blvd., Suite 1600
    City
    Golden Valley
    State
    MN
    Postal Code
    55416
    Country
    US
    Correspondent
    Joel C Aaberg

    Products

    Device Name Product Code
    Stimulator, Hypoglossal Nerve, Implanted, Apnea MNQ

    Proprietary Names

    Model 3028 MR Conditional Implantable Pulse Generator Model 3024 Implantable Pulse Generator Model 4063 Stimulation Lead Model 3032 Sleep Remote Model 2740 Physician Programmer Model 2500 Sleep Remote Model 4323 Sensing Lead Model 4340 Sensing Lead Model 2580 Sleep Remote SleepSync Model 2740S Inspire Programming Software Application Model 3150 MR Conditional Implantable Pulse Generator SleepSync Model 2740C Inspire Programmer Cable

    Establishment Types

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