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    FDA Registration Active 🇺🇸 United States

    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

    Reg #: 3004209178 · FEI: 3004369318 · Expires 2026
    View on FDA
    Products
    26
    Proprietary Names
    114
    Establishment Types
    2
    Classifications
    26

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    Registration Details

    Registration Name
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Registration Number
    3004209178
    FEI Number
    3004369318
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ROAD 31, KM. 24, HM 4, CEIBA NORTE INDUSTRIAL PARK
    City
    Juncos
    State
    PR
    ZIP
    00777
    Country
    US

    Regulatory Submissions

    510(k) Number
    K960631
    PMA Number
    P840001

    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
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Pump, Infusion, Implanted, Programmable LKK
    Instrument, Surgical, Non-Powered HAO
    Stimulator, Electrical, Implantable, For Incontinence EZW
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Implantable Pacemaker Pulse-Generator DXY
    Dissector, Surgical, General & Plastic Surgery GDI
    Implanted Subcortical Electrical Stimulator (Motor Disorders) MRU
    Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) OLM
    Intestinal Stimulator LNQ
    Stimulator, Brain, Implanted, For Behavior Modification MFR
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence QON
    Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence QPT
    Orthopedic Stereotaxic Instrument OLO
    Posterior Cervical Screw System NKG
    Stimulator, Thalamic, Epilepsy, Implanted MBX
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Deep Brain Stimulation For The Treatment Of Dystonia SGS

    Proprietary Names

    accessory kit screening cable PrimeAdvanced SureScan MRI Neurostimulator Injex Bumpy Anchor Pisces-Quad Plus Lead N'Vision Software Application Card Specify SureScan MRI Lead Pisces-Quad Compact Lead Resume II Lead RestoreUltra SureScan MRI Neurostimulator Itrel 4 Neurostimulator Resume TL Lead Titan Anchor RestoreSensor Neurostimulator Itrel 4 Neurostimulation System Stretch Coil Extension RestoreAdvanced Neurostimulator EZ Anchor Injex BiWing Anchor RestoreAdvanced SureScan MRI Neurostimulator Specify Lead Vectris SureScan Lead RestorePrime Neurostimulator Itrel EZ Programmer Synergy EZ Programmer RestoreUltra Neurostimulator RestoreSensor SureScan MRI Neurostimulator PrimeAdvanced Neurostimulator myStim Programmer N'Vision Programmer Intellis™ with AdaptiveStim™ Implantable Neurostimulator Vanta™ with AdaptiveStim™ Implantable Neurostimulator Inceptiv™ LT Implantable Neurostimulator Inceptiv™ Implantable Neurostimulator Intellis™ Pro Implantable Neurostimulator SynchroMed Infusion Pump System SynchroMed II Infusion Pump System myPTM Personal Therapy Manager Ascenda Catheter Indura 1P Catheter SynchroMed® II Clinician Programmer PumpSynchroMed™ Clinician Programmer SynchroMed™ III Pocket sizer DBS Tunneling tool Tunneling Tool Accessory Kit SenSight™ InterStim II Neurostimulator InterStim Neurostimulator Verify Controller Verify Evaluation System InterStim Sacral Nerve Stimulation InterStim iCon Patient Programmer Verify External Neurostimulator InterStim II Sacral Nerve Stim InterStim Micro™ Implantable Neurostimulator InterStim™ SureScan™ MRI leads InterStim™ X Implantable Neurostimulator 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 MEROCEL SPONGE MICRO-FRANCE Medtronic Dissector Tool Access Review Therapy Controller Activa PC Neurostimulator Activa SC Neurostimulator DBS Therapy for Dystonia DBS Extension Kit StimLoc Activa Dystonia Therapy Percept™ PC BrainSense™ MLTC Multi Lead Trialing Cable Enterra Neurostimulator extension Access Therapy Controller Reclaim Deep Brain Stimulation InterStim Therapy System InterStim iCon Programmer extension passer Altaviva™ Patient Programmer Kit Altaviva™ Neurostimulator Patient Programmer Altaviva™ Clinician Kit Wireless Recharger Altaviva™ Clinician Programmer Kit Recharging Dock Ankle Band INFINITY™ Occipitocervical Upper Thoracic System Activa Tremor Control Therapy Activa RC Neurostimulator Activa Parkinsons Control Therapy Intercept™ Percept™ RC Rechargeable Neurostimulator with BrainSense™ Technology

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)