BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    Medtronic Singapore Operations Pte Ltd

    Reg #: 3008973940 · FEI: 3008973940 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    42
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    Medtronic Singapore Operations Pte Ltd
    Registration Number
    3008973940
    FEI Number
    3008973940
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    49 Changi South Avenue 2, Nasaco Tech Centre
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K233320
    PMA Number
    P930039

    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
    Permanent Pacemaker Electrode DTB
    Permanent Defibrillator Electrodes NVY
    Medical Device Data System OUG
    Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) MXD
    Detector And Alarm, Arrhythmia DSI
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Implantable Pacemaker Pulse-Generator DXY

    Proprietary Names

    CapSureFix Lead CapSureFix Novus MRI SureScan Leads Vitatron Crystalline Lead SureFix CapSureFix Novus Leads LINQ II™ Insertable Cardiac Monitor (LNQ22) LINQ II™ Insertable Cardiac Monitor (ICM) LINQ Tool Kit LINQ II Insertable Cardiac Monitor Capsure SP Novus CapSure Sense Adhesive Vitatron Excellence PS+ Lead stylet kit CapSure Unipolar Lead CapSure Sense MRI SureScan Leads Reveal LINQ Advisa DR MRI SureScan Advisa DR Adapta InCheck Patient Assistant Relia IPG Adapta L Adapta S Advisa SR MRI SureScan Versa DR IPG Sensia DR IPG Azure XT DR MRI Azure S SR MRI Azure XT SR MRI Azure S DR MRI CareLink SmartSync Azure Astra Application Sphera DR MRI Attesta L DR MRI Attesta SR MRI Attesta S DR MRI Attesta DR MRI Sphera SR MRI Sphera L DR MRI Sensia IPG CapSureFix MRI SureScan Lead Revo MRI SureScan

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device