BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Relia IPG

    Reg #: 3003120897 · FEI: 3003120897 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Registration Number
    3003120897
    FEI Number
    3003120897
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4340 Swinnea Road
    City
    Memphis
    State
    TN
    ZIP
    38118
    Country
    US

    Regulatory Submissions

    PMA Number
    P980035

    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
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Implantable Pacemaker Pulse-Generator DXY

    Proprietary Names

    Relia IPG Adapta L Adapta S Advisa DR MRI SureScan Sensia DR IPG Adapta Versa DR IPG InCheck Patient Assistant Advisa SR MRI SureScan Advisa DR Azure S DR MRI Azure XT SR MRI Azure XT DR MRI Azure S SR MRI Attesta L DR MRI Sphera DR MRI CareLink SmartSync Azure Astra Application Attesta S DR MRI Attesta DR MRI Attesta SR MRI Sphera L DR MRI Sphera SR MRI Sensia IPG

    Establishment Types

    Manufacture Medical Device