BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HomeStream Remote Management

    Reg #: 3027063190 · FEI: 3027063190 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOTRONIK NRO, INC.
    Registration Number
    3027063190
    FEI Number
    3027063190
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    6024 Jean Road
    City
    Lake Oswego
    State
    OR
    ZIP
    97035
    Country
    US

    Regulatory Submissions

    PMA Number
    P210037

    Owner / Operator

    Firm Name
    Biotronik NRO, INC.
    Operator Number
    10087752
    Address
    6024 Jean Road
    City
    Lake Oswego
    State
    OR
    Postal Code
    97035
    Country
    US
    Correspondent
    Wee Wen Leow

    Products

    Device Name Product Code
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW

    Proprietary Names

    HomeStream Remote Management TrueLock Embrace One Prospera Spinal Cord Stimulation (SCS) System Resilience Percutaneous Lead

    Establishment Types

    Repack or Relabel Medical Device