Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004209178

FEI Number

3004369318

Entity Name

MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS

City/State/Country

Juncos, PR, US

Establishment Address

ROAD 31, KM. 24, HM 4, CEIBA NORTE INDUSTRIAL PARK, Juncos, PR 00777, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

N/A

PMA Number

N/A

All Registered 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 N'Vision Software Application Card SynchroMed Infusion Pump System SynchroMed II Infusion Pump System myPTM Personal Therapy Manager Ascenda Catheter Indura 1P Catheter N'Vision Programmer 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 N'Vision Software Application Card N'Vision Programmer 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 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 MLTC Multi Lead Trialing Cable N'Vision Software Application Card Enterra Neurostimulator N'Vision Programmer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2007-12-26
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2007-12-26
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
LKK	Pump, Infusion, Implanted, Programmable	Unknown	Class 3	N/A	2006-04-21
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2012-02-28
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	2007-01-24
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2007-01-24
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2007-01-24
DXY	Implantable Pacemaker Pulse-Generator	Cardiovascular	Class 3	870.3610	2007-01-24
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1994-11-09
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
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2010-11-29
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2010-11-29
LNQ	Intestinal Stimulator	Unknown	Class f	N/A	2007-12-27

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
K190960	Boston Scientific Neuromodulation	Nalu Lead Blank (50cm)	2019-07-11
K150517	Stimwave Technologies Incorporated	Freedom Spinal Cord Stimulator System	2015-06-05
K945103	Medtronic Vascular	TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS)	1995-01-11

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004209178. Last updated year: 2026. Please use registration number 3004209178 when referencing this establishment in official correspondence.