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Medtronic Puerto Rico Operations Co., Juncos: FDA-registered device maker in Juncos, PR, United States, 5 510(k) clearances and 7 PMA approvals

Name: Medtronic Puerto Rico Operations Co., Juncos FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medtronic Puerto Rico Operations Co., Juncos is registered with the FDA (registration 3004209178) in Juncos, PR, United States. It lists 26 device types. The FDA files 5 510(k) clearances and 7 PMA approvals under its listings, the newest dated October 24, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3004209178
FEI number: 3004369318
Address: Road 31, KM. 24, HM 4 Ceiba Norte Industrial Park, Juncos, PR, United States, 00777
Owner or operator: Medtronic, Inc. (2112641)
Roles: Contract manufacturer, Manufacturer
First device listed: November 9, 1994
Registered through: 2027
Brand names listed: Access Review Therapy Controller, Access Therapy Controller, Activa Dystonia Therapy, Activa PC Neurostimulator, Activa Parkinsons Control Therapy, Activa RC Neurostimulator, Activa SC Neurostimulator, Activa Tremor Control Therapy and more

Devices it lists

Device	Product code	Class	Role	Source
Deep Brain Stimulation For The Treatment Of Dystonia	SGS	3	Manufacturer	accessdata.fda.gov
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)	OLM	f	Manufacturer	accessdata.fda.gov
Dissector, Surgical, General & Plastic Surgery	GDI	1	Manufacturer	accessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes	NVN	3	Manufacturer	accessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)	LWS	3	Manufacturer	accessdata.fda.gov
Implantable Pacemaker Pulse-Generator	DXY	3	Manufacturer	accessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)	LWP	3	Manufacturer	accessdata.fda.gov
Implanted Electrical Device Intended For Treatment Of Fecal Incontinence	QON	3	Manufacturer	accessdata.fda.gov
Implanted Subcortical Electrical Stimulator (Motor Disorders)	MRU	f	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Non-Powered	HAO	1	Manufacturer	accessdata.fda.gov
Intestinal Stimulator	LNQ	f	Contract manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
Posterior Cervical Screw System	NKG	2	Manufacturer	accessdata.fda.gov
Pulse Generator, Permanent, Implantable	NVZ	3	Manufacturer	accessdata.fda.gov
Pump, Infusion, Implanted, Programmable	LKK	3	Manufacturer	accessdata.fda.gov
Stimulator, Brain, Implanted, For Behavior Modification	MFR	f	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implantable, For Incontinence	EZW	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential Tremor	PJS	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	NHL	3	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian Tremor	MHY	3	Manufacturer	accessdata.fda.gov
Stimulator, Peripheral Nerve, Implanted (Pain Relief)	GZF	2	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Implanted (Pain Relief)	GZB	2	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	LGW	3	Manufacturer	accessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	QRB	3	Manufacturer	accessdata.fda.gov
Stimulator, Thalamic, Epilepsy, Implanted	MBX	3	Manufacturer	accessdata.fda.gov
Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence	QPT	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 24, 2025	K253129	Infinity OCT System	NKG	Substantially Equivalent	Medtronic Sofamor Danek USA, Inc.	accessdata.fda.gov
October 26, 2010	K102523	MULTI-LEAD TRIALING CABLE MODEL 355531	GZB	Substantially Equivalent	Medtronic, Inc.	accessdata.fda.gov
April 12, 2000	K000105	MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),	GZF	Substantially Equivalent	Medtronic Vascular	accessdata.fda.gov
May 21, 1996	K960631	MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX	GZF	Substantially Equivalent	Medtronic Vascular	accessdata.fda.gov
November 5, 1992	K923567	MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD	GZB	Substantially Equivalent	Medtronic Vascular	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 18, 2025	P240011	Medtronic Altaviva System	QPT	15	September 14, 2026	accessdata.fda.gov
March 14, 2011	P080025	MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM	QON	349	October 9, 2026	accessdata.fda.gov
January 29, 1999	P980035	MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE	NVZ	822	October 23, 2026	accessdata.fda.gov
September 29, 1997	P970004	MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL	EZW	448	October 9, 2026	accessdata.fda.gov
July 31, 1997	P960009	MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM	MHY	528	October 6, 2026	accessdata.fda.gov
March 14, 1988	P860004	MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM	LKK	442	October 16, 2026	accessdata.fda.gov
November 30, 1984	P840001	ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS	LGW	612	October 6, 2026	accessdata.fda.gov

Compare with other makers

Updated September 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.