BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

    Reg #: 2649622 · FEI: 2649622 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    235
    Establishment Types
    4
    Classifications
    36

    Registration Details

    Registration Name
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Registration Number
    2649622
    FEI Number
    2649622
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    RD. 149, KM. 56.3, Call Box 6001
    City
    Villalba
    State
    PR
    ZIP
    00766
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190132
    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, Totally Implanted For Pain Relief LGW
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) NKE
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Pulse Generator, Permanent, Implantable NVZ
    Implantable Pacemaker Pulse-Generator DXY
    Programmer, Pacemaker KRG
    Implantable Pulse Generator, Pacemaker (Non-Crt) LWP
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Catheter, Electrode Recording, Or Probe, Electrode Recording DRF
    Stylet, Catheter DRB
    Permanent Pacemaker Electrode DTB
    Pacemaker Lead Adaptor DTD
    Implanted Subcortical Electrical Stimulator (Motor Disorders) MRU
    Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd) OLM
    Cardiac Ablation Percutaneous Catheter LPB
    Permanent Defibrillator Electrodes NVY
    Tools, Pacemaker Service DTF
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE
    Stimulator, Brain, Implanted, For Behavior Modification MFR
    Stimulator, Electrical, Implantable, For Incontinence EZW
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode OJX
    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
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Catheter, Percutaneous DQY
    Catheter, Flow Directed DYG
    Intestinal Stimulator LNQ
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF
    Implanted Electrical Device Intended For Treatment Of Fecal Incontinence QON
    Instruments, Surgical, Cardiovascular DWS
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    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 Analyzer Adapter Prodigy IPG Medtronic CareLink Monitor Service Kit Adapter Cable Sterile Plastic Sleeve CapSure Lead CareLink Express Mobile System - Android CapSure VDD-2 Lead CareLink Express Monitor ECG Port Plug ECG Output Adapter CareLink Wireless Network Adapter Card Program Interface Cable CareLink Express Mobile System - iOS CareLink Encore Programmer Analyzer Cable ECG Cable Lead Analyzer MyCareLink Patient Monitor CardioSight Reader CareLink Encore Programmer RF Head CareLink Programmer RF Head Medtronic CareLink Programmer CareLink SmartSync Power Cord 249705 CareLink SmartSync Patient Connector 24967 CareLink SmartSync Base 24970A CareLink SmartSync PSA Application CareLink SmartSync Common Application iOS CareLink SmartSync Power Supply 249701 Integrated Diagnostics Data Calculation Module Model 5242 Instrument Command Library (ICL)Device Command Library (DCL) CapSureFix MRI SureScan Lead Revo MRI SureScan Torqr Intracardiac Electrode Catheter Soloist Intracardiac Electrode Catheter stylet kit Myocardial Pacing Lead Marinr Steerable Intracardiac Electrode Catheter StableMapr Steerable Intracardiac Electrode Catheter temporary lead extension Access Review Therapy Controller Activa PC Neurostimulator Activa SC Neurostimulator DBS Therapy for Dystonia DBS Extension Kit StimLoc Activa Dystonia Therapy Percept™ PC BrainSense™ SenSight™ ATAKR Accessory RF ENHANCR II RF CONTACTR Cable RF MARINR RF CONDUCTR Capsure SP Novus Vitatron Crystalline Lead CapSure Sense Adhesive Vitatron Excellence PS+ Lead CapSure Unipolar Lead CapSure Sense MRI SureScan Leads Torclip Pacemaker Repair Kit Freezor MAX cardiac cryoablation catheter Arctic Front Advance cardiac cryoablation catheter Arctic Front Advance ProTM CapSure Z Novus MRI SureScan Lead Anchoring Sleeve Kit Access Therapy Controller Reclaim Deep Brain Stimulation 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 CapSureFix Lead CapSureFix Novus MRI SureScan Leads SureFix CapSureFix Novus Leads LEAD END CAP KIT Lead anchoring Sleeve SELECTSECURE SelectSecure MRI SureScan Adaptor Extender Kit Sprint Quattro Secure MRI SureScan Lead DF-1 Port Pin Plug Subcutaneous Lead Tunneling Tool Sprint Quattro Secure S MRI SureScan Lead Sprint Quattro Secure S Lead Sprint Quattro MRI SureScan Lead Sprint Quattro Lead Transvene Lead Transvene SVC Lead Adaptor Kit IS-1 Port Pin Plug Kit Sprint Quattro Secure Lead SOLOIST MARINR TORQR Cables Syncra CRT-P Attain Viva CRT-P Solara CRT-P MRI SureScan Percepta CRT-P MRI SureScan Solara Quad CRT-P MRI SureScan Insync Attain Bipolar OTW Lead Consulta CRT-P Percepta Quad CRT-P MRI SureScan Attain OTW Serena CRT-P MRI SureScan Serena Quad CRT-P MRI SureScan CareLink SmartSync Percepta, Solera, Serena Application StableMapr Activa Tremor Control Therapy Activa RC Neurostimulator Activa Parkinsons Control Therapy Intercept™ Percept™ RC Rechargeable Neurostimulator with BrainSense™ Technology 1 X 8 Test Stimulation Lead Model 3873 1 X 8 Lead Model 3874 1 X 8 Compact Lead Attain Prevail 6228 CTH PIN PLUG KIT Enterra Neurostimulator On-Point Lead Attain StarFix InterStim Therapy System InterStim iCon Programmer Lead Adaptor MITRAL COLLAR AND TIE Actuators Rotation Tool Kit AORTIC CUFF Universal Mounting Rail pinch on tool MEDIUM BLADE SET TOOL Lead Accessory Kit Adjustable Slitter Implant Tool Kit ATRIAL LIFT SYSTEM Accessory Port ATS Medical Thoracic Port System EXTRA LG BLADE SET TOOL INTERCOSTAL RETRACTOR SYSTEM SUTURE BELT LARGE BLADE SET TOOL STERILIZATION TRAY TOOL RETRACTOR RACK TOOL SMALL BLADE SET TOOL Mounting Rail Universal II Slitter Impulse II Lead CapSure SP Novus CapSure Z Novus CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025 Epsila EV™ MRI SureScan™ extravascular lead Aurora EV-ICD™ MRI SureScan™ extravascular implantable cardioverter defibrillator Epsila EV™ Sternal Tunneling Tool AURORA EV-ICD™ MRI SURESCAN™ SW041 Epsila EV™ Transverse Tunneling Tool OmniaSecure™ MRI SureScan™ PCD End Cap GEM Patient Cable Lead Patch MICRO JEWEL Patient Magnet MICRO JEWEL II Ace Header Emulator Epicardial Patch Lead Upsizing Sleeve Sizing Sleeve GEM VR 3875 1 X 8 Subcompact Lead Attain Ability Lead Attain Performa MRI SureScan Lead Attain Performa S MRI SureScan Lead Attain Performa S Lead Attain Ability MRI SureScan Lead Attain Ability Straight Lead Attain Performa Straight MRI SureScan Lead Attain Ability Straight MRI SureScan Lead Attain Performa Straight Lead Attain Ability Plus Lead Attain Performa Lead Attain Ability Plus MRI SureScan Lead Attain Stability Quad MRI SureScan Lead CapSure Epicardial Pacing lead BIPOLAR PENCIL

    Establishment Types

    Manufacture Medical Device Manufacture Device in the United States for Export Only Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)