Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2649622

FEI Number

2649622

Entity Name

MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA

City/State/Country

Villalba, PR, US

Establishment Address

RD. 149, KM. 56.3, Call Box 6001, Villalba, PR 00766, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K040568

PMA Number

N/A

All Registered 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 stylet kit temporary lead extension Access Review Therapy Controller Activa PC Neurostimulator N'Vision Programmer Activa SC Neurostimulator DBS Therapy for Dystonia N'Vision Software Application Card 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 stylet kit 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 Activa PC Neurostimulator Access Review Therapy Controller Activa SC Neurostimulator DBS Extension Kit N'Vision Software Application Card Access Therapy Controller Reclaim Deep Brain Stimulation N'Vision Programmer Percept PC BrainSense 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 N'Vision Software Application Card N'Vision Programmer InterStim Micro Implantable Neurostimulator InterStim SureScan MRI leads InterStim X Implantable Neurostimulator CapSureFix Lead CapSureFix Novus MRI SureScan Leads Vitatron Crystalline Lead 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 Myocardial Pacing Lead TORQR Cables stylet kit 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 Access Therapy Controller Activa RC Neurostimulator Activa PC Neurostimulator N'Vision Software Application Card StimLoc Activa SC Neurostimulator DBS Extension Kit Access Review Therapy Controller N'Vision Programmer Activa Parkinsons Control Therapy Intercept Percept PC BrainSense SenSight 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 Attain N'Vision Software Application Card Enterra Neurostimulator N'Vision Programmer On-Point Lead

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2007-12-06
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2007-12-06
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2007-01-24
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2007-01-24
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-01-24
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-01-24
KRG	Programmer, Pacemaker	Cardiovascular	Class 3	870.3700	2007-01-24
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2011-02-10
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2011-02-10
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2011-02-10
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2020-07-09
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2011-08-15
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2015-05-13
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2020-07-09
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2015-12-17
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2011-05-25
MRU	Implanted Subcortical Electrical Stimulator (Motor Disorders)	Unknown	Class f	N/A	2008-06-09
OLM	Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)	Unknown	Class f	N/A	2008-06-09
LPB	Cardiac Ablation Percutaneous Catheter	Unknown	Class 3	N/A	2007-12-12
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2008-03-12
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2008-03-12
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2008-03-12
DTF	Tools, Pacemaker Service	Cardiovascular	Class 1	870.3730	2008-04-09
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2013-03-28
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2017-11-08
MFR	Stimulator, Brain, Implanted, For Behavior Modification	Unknown	Class f	N/A	2010-05-12
OLM	Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)	Unknown	Class f	N/A	2010-05-12
EZW	Stimulator, Electrical, Implantable, For Incontinence	Gastroenterology, Urology	Class 3	876.5270	2007-12-26
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2007-12-06
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2007-12-06
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2007-12-06
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2011-05-25
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2007-01-22
NVN	Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	Unknown	Class 3	N/A	2007-01-22
NVY	Permanent Defibrillator Electrodes	Unknown	Class 3	N/A	2008-03-12
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2008-03-12
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2011-12-15
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2010-07-02
DTB	Permanent Pacemaker Electrode	Cardiovascular	Class 3	870.3680	2013-04-12
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2011-12-15
DRB	Stylet, Catheter	Cardiovascular	Class 2	870.1380	2009-06-09
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-01-23
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2007-01-23
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2007-01-23
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-01-23
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2010-08-10
MBX	Stimulator, Thalamic, Epilepsy, Implanted	Unknown	Class 3	N/A	2006-01-18
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2006-01-18
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Unknown	Class 3	N/A	2006-01-18
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Unknown	Class 3	N/A	2006-01-18
SGS	Deep Brain Stimulation For The Treatment Of Dystonia	Unknown	Class 3	N/A	2006-01-18
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2007-12-26
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-01-16
DYG	Catheter, Flow Directed	Cardiovascular	Class 2	870.1240	2008-03-12
LNQ	Intestinal Stimulator	Unknown	Class f	N/A	2007-12-27
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	1992-12-02
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	1992-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

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3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K854482	Medtronic Vascular	ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS	1986-02-28
K790690	Cordis Corp.	OMNI-STANICOR-(THETA) MODEL 217	1979-05-16
K881966	C.R. Bard, Inc.	ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER	1988-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026	Abbott Medical	3	Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

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3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2649622. Last updated year: 2026. Please use registration number 2649622 when referencing this establishment in official correspondence.