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Data / Medical devices / United States / Medtronic Puerto Rico Operations Co., Villalba

Medtronic Puerto Rico Operations Co., Villalba: FDA-registered device maker in Villalba, PR, United States, 20 510(k) clearances and 22 PMA approvals

Medtronic Puerto Rico Operations Co., Villalba is registered with the FDA (registration 2649622) in Villalba, PR, United States. It lists 36 device types. The FDA files 20 510(k) clearances and 22 PMA approvals under its listings, the newest dated April 22, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Medtronic Puerto Rico Operations Co., Villalba
FDA registration number
2649622
Address
RD. 149, KM. 56.3 Call Box 6001, Villalba, PR, United States, 00766
Owner or operator
Medtronic, Inc. (2112641)
Roles
Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
First device listed
December 2, 1992
Registered through
2026
Brand names listed
1 X 8 Test Stimulation Lead, 3875 1 X 8 Subcompact Lead, AORTIC CUFF, ATAKR, ATRIAL LIFT SYSTEM, AURORA EV-ICD™ MRI SURESCAN™ SW041, Access Review Therapy Controller, Access Therapy Controller and more

Devices it lists

DeviceProduct codeClassRoleSource
Cardiac Ablation Percutaneous CatheterLPB3Manufactureraccessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode RecordingDRF2Manufactureraccessdata.fda.gov
Catheter, Flow DirectedDYG2Manufactureraccessdata.fda.gov
Catheter, PercutaneousDQY2Manufactureraccessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial FibrillationOAE3Manufactureraccessdata.fda.gov
Deep Brain Stimulation For The Treatment Of DystoniaSGS3Manufactureraccessdata.fda.gov
Deep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)OLMfManufactureraccessdata.fda.gov
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker ElectrodeOJX3Manufacturer, Repackager or relabeleraccessdata.fda.gov
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesNVN3Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)LWS3Manufactureraccessdata.fda.gov
Implantable Pacemaker Pulse-GeneratorDXY3Manufactureraccessdata.fda.gov
Implantable Pulse Generator, Pacemaker (Non-Crt)LWP3Manufacturer, Repackager or relabeleraccessdata.fda.gov
Implanted Electrical Device Intended For Treatment Of Fecal IncontinenceQON3Manufactureraccessdata.fda.gov
Implanted Subcortical Electrical Stimulator (Motor Disorders)MRUfManufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Manufactureraccessdata.fda.gov
Intestinal StimulatorLNQfContract manufactureraccessdata.fda.gov
Pacemaker Lead AdaptorDTD2Manufactureraccessdata.fda.gov
Pacemaker/Icd/Crt Non-Implanted ComponentsOSR3Manufactureraccessdata.fda.gov
Permanent Defibrillator ElectrodesNVY3Manufactureraccessdata.fda.gov
Permanent Pacemaker ElectrodeDTB3Manufacturer, Manufacturer for exportaccessdata.fda.gov
Programmer, PacemakerKRG3Manufactureraccessdata.fda.gov
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)NKE3Manufacturer, Repackager or relabeleraccessdata.fda.gov
Pulse Generator, Permanent, ImplantableNVZ3Manufacturer, Repackager or relabeleraccessdata.fda.gov
Stimulator, Brain, Implanted, For Behavior ModificationMFRfManufactureraccessdata.fda.gov
Stimulator, Electrical, Implantable, For IncontinenceEZW3Manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Essential TremorPJS3Manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian SymptomsNHL3Manufactureraccessdata.fda.gov
Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY3Manufactureraccessdata.fda.gov
Stimulator, Peripheral Nerve, Implanted (Pain Relief)GZF2Manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Implanted (Pain Relief)GZB2Manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW3Manufactureraccessdata.fda.gov
Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic NeuropathyQRB3Manufactureraccessdata.fda.gov
Stimulator, Thalamic, Epilepsy, ImplantedMBX3Manufactureraccessdata.fda.gov
Stylet, CatheterDRB2Manufactureraccessdata.fda.gov
Tools, Pacemaker ServiceDTF1Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 30, 2019K190132Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode CatheterDRFSubstantially EquivalentMedtronicaccessdata.fda.gov
July 30, 2019K183547Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode CatheterDRFSubstantially EquivalentMedtronicaccessdata.fda.gov
August 16, 2006K062041MODEL 3875 1 X 8 SC TEST STIMULATION LEADGZBSubstantially EquivalentMedtronic, Inc.accessdata.fda.gov
July 28, 2005K051773MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADSGZBSubstantially EquivalentMedtronic Inc.,Neurological Division.accessdata.fda.gov
March 25, 2004K040568POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADSGZBSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
July 17, 2003K031211ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTHDQYSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
May 22, 2003K031274MODEL 5071 MYOCARDIAL PACING LEADDTBSubstantially Equivalent - Subject to Tracking Reg.Medtronic Vascularaccessdata.fda.gov
August 28, 2001K012225ATTAIN 6215 VENOGRAM BALLOON CATHETERDYGSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
May 3, 2001K010487BIPOLAR PENCIL, MODEL 3901-002, 3900-002GEISubstantially EquivalentMedtronic PS Medicalaccessdata.fda.gov
April 5, 2001K010906MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254DRBSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
February 8, 2001K003535STYLET KIT, MODELS 6254,6282,6293DRBSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
August 5, 1998K981642STABLEMAPR STEERABLE INTRACARDIAC CATHETERSDRFSubstantially EquivalentMedtronic Cardiorhythmaccessdata.fda.gov
April 15, 1996K953185PLATINUM SERIES EP DIAGNOSTIC CATHETERSDRFSubstantially EquivalentMedtronic Cardiorhythmaccessdata.fda.gov
May 10, 1995K951347MARINR SERIES EP DIAGNOSTI CATHETERSDRFSubstantially EquivalentMedtronic Cardiorhythmaccessdata.fda.gov
June 6, 1994K931794MARINR SERIES EP DIAGNOSTIC CATHETERSDRFSubstantially EquivalentMedtronic Cardiorhythmaccessdata.fda.gov
February 10, 1993K923915TORQR SERIES DIAGNOSTIC EP CATHETERSDRFSubstantially EquivalentCardiorhythmaccessdata.fda.gov
March 9, 1992K915563DIAGNOSTIC EP CATHETERDRFSubstantially EquivalentArrhythmia Technologies, Inc.accessdata.fda.gov
April 18, 1991K911048MODEL 5857-3M LEAD END CAP KITDTDSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
April 18, 1991K910630MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KITDTDSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov
December 1, 1980K801284LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)DTBSubstantially EquivalentMedtronic Vascularaccessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
April 22, 2025P240036OmniaSecure™ MRI SureScan™ Lead Model 3930MNVY7October 23, 2026accessdata.fda.gov
October 20, 2023P220012Aurora EV-ICD SystemLWS75July 31, 2026accessdata.fda.gov
April 27, 2015P120017MODEL 5071 LEADDTB40April 15, 2026accessdata.fda.gov
March 14, 2011P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMQON349October 9, 2026accessdata.fda.gov
February 8, 2011P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP325June 5, 2025accessdata.fda.gov
December 17, 2010P100010ARCTIC FRONT CRYOCATHETER SYSTEMOAE151September 25, 2026accessdata.fda.gov
April 7, 2009P080006MEDTRONIC ATTAIN ABILITY MODEL 4196 LEADOJX191June 24, 2026accessdata.fda.gov
June 13, 2008P060039ATTAIN STARFIX MODEL 4195 LEADOJX116February 10, 2026accessdata.fda.gov
August 3, 2005P030036MEDTRONIC SELECTSECURE LEAD MODEL 3830NVN159October 16, 2026accessdata.fda.gov
August 28, 2001P010015MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMLWP574October 23, 2026accessdata.fda.gov
June 14, 2000P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOFLWS142April 15, 2026accessdata.fda.gov
September 29, 1997P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW448October 9, 2026accessdata.fda.gov
July 31, 1997P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY528October 6, 2026accessdata.fda.gov
September 6, 1996P950024MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695NVN114April 15, 2026accessdata.fda.gov
March 29, 1996P930039MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568NVN267June 24, 2026accessdata.fda.gov
February 9, 1995P930029ATAKR(TM) RFCA SYSTEMLPB66July 1, 2024accessdata.fda.gov
December 9, 1993P920015MEDTRONIC(R) TRANSVENE LEAD SYSTEMNVY294August 19, 2026accessdata.fda.gov
February 11, 1993P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS170April 15, 2026accessdata.fda.gov
August 24, 1989P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ459July 31, 2026accessdata.fda.gov
July 29, 1986P850089CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADSNVN167April 15, 2026accessdata.fda.gov
July 29, 1986P830061STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACINGNVN225June 24, 2026accessdata.fda.gov
November 30, 1984P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW612October 6, 2026accessdata.fda.gov

Compare with other makers

Updated October 23, 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.