Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1627487

FEI Number

1627487

Entity Name

Abbott Medical

City/State/Country

PLANO, TX, US

Establishment Address

6901 Preston Rd, PLANO, TX 75024, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ABBOTT LABORATORIES (Owner Number: 1415939)

Owner / Operator Contact Address

100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K960728

PMA Number

N/A

All Registered Proprietary Names

NRFE-10 NRFE-5 NRFE-15 AXIUM NEUROSTIMULATOR SYSTEM SlimTip DRG Implant Lead St. Jude Medical Patient Controller App DRG EPG Kit Accessories DRG Lead Extension DRG Connector Cable DRG Small Curve Delivery Sheath DRG External Pulse Generator, 2 Port Header DRG Lead Accessories Kit DRG Curved Needle DRG External Pulse Generator, 8 Channel St. Jude Medical Clinician Programmer App DRG Big Curve Delivery Sheath Proclaim DRG Implantable Pulse Generator DRG Tunneling Tool SlimTip DRG Trial Lead Patient Magnet NeuroSphere Digital Health App (3876) Swift-Lock Anchor Tunneling Tool (models 1112, 1120, 1190, 1191) Disposable RF Electrode (RFDE-5, RFDE-10, RFDE-15, RFDE-20) IonicRF Generator Trial System Trial cable (model 3009) MTS Trial Cable 6720, Brio LE Charger Accessory 6722, BrioLE Charging System NeuroSphere Digital Health App (3876) Patient Magnet (Model 1210) Port Plug (model 12710) BurstDR stimulation temp evaluation patient programmer (Model 3857) Tripole 16 Lamitrode (Model 3219) Power Cord, Portable Charger (Model 3714) Proclaim 7 IPG (Medtronic header) (Model 3663) Stylet, Bent, 90cm (Model 1126) Eon Charging System (Model 3726) Quattrode Percutaneous Lead Kit, 30cm, 3/4 Spacing (Model 3143) Octrode Percutaneous Lead Kit, 60cm (Model 3186) Prodigy MRI patient programmer (Model 3856) Lamitrode Percuatenous , 8 electrode, 90cm (Model 3268) Charger (Model 3721) Strain Relief (Model 1109) Rapid Programmer (Model 3834) IRDA communication cable (Model 1280) Octrode Percutaneous Lead Kit, 30cm (Model 3183) Quattrode Percutaneous Lead Kit, 60cm, 3/4 Spacing (Model 3146) Battery pack (Model 1254) A127 Lead Extension SCS EPG 2-Port Header (Model 3032) Cinch Lead Anchor (Model 1194) Genesis Programmer (Model 3850) Stylet, Straight, 60cm (Model 1123) TriCentrus, 16 Lead 60cm Length (Model 3292) NeuroSphere Patient Controller (model 55500) Torque Wrench (Model 1101) Charger Antenna 36" (Model 3732) Prodigy patient programmer (Model 3855) Power adapter, rapid programmer (Model 1622) Charger (model 16000) Eon Mini Charging System (Model 3722) 8-Channel Adapter, B, 10cm (Model 2321) Stylet, Bent, 30cm (Model 1122) Introde-AK Lead Introducer (Model 1103) Proclaim 7 IPG (Model 3667) Proclaim Plus 7 (Medtronic header) (Model 3673) Swift-Lock Anchor (Model 1192) Patient Programmer (Model 3852) Proclaim 5 Elite IPG (Model 3660) Prodigy Charger (Model 3730) Proclaim 5 IPG (Model 3665) Proclaim Plus 5 (Medtronic header) (Model 3671) Eon LE Mobile Charger (Model 3726) Quattrode Percutaneous Lead Kit, 60cm, 3/6 Spacing (Model 3156) EonC (Model 3688) Lamitrode 4 Surgical Lead Kit, 60cm (Model 3240) Quattrode Percutaneous Lead Kit, 30cm, 3/6 Spacing (Model 3153) External Pulse Generator (EPG) (Model 3599) C-Series Lamitrode Leads (Models 3245) St. Jude Medical Clinician Programmer (Model 3874) Eon Mini (Model 3788) Pouch, Portable Charger (Model 7241) Eon Patient Programmer (Model 3851) Lamitrode 44 Surgical Lead Kit, 60cm (Model 3244) SCS Accessory Kit Sterile (Model 1701) Dual Extension (Models 3341, 3343, 3346) S-Series Lamitrode Leads (Models 3243, 3283, 3246, 3286) Stylet, Bent, 60cm (Model 1124) Proclaim 7 Elite IPG (Model 3662) Patient Wand (Model 1232) Charging Apparel, lumbar (model 16750) St. Jude Medical Patient Controller (Model 3875) Quattrode® Trial Lead Wide Spaced (Model 3066) Stylet, Straight, 30cm (Model 1121) Octrode Lead, 8 electrode, 3/4mm, 90cm (Model 3189) Penta Lead (Model 3228) Port Plug Accessory kit (Model 1108) Lead Anchor, Long (Model 1106) SCS Charging System (model 36700) Port Plug Accessory Kit (Model 1111) Proclaim Plus 7 (Model 3672) Quattrode Lead, 4 electrode, 3/4mm, 90cm (Model 3149) Lead Anchor, Butterfly (Model 1105) NeuroSphere Clinician Programmer (model 55600) EPG Non-Adhesive Pouch (Model 1214) Protege MRI IPG (Model 3771) Lamitrode® 88 Lead Kit, 60cm Length (Model 3288) Stylet, Straight, 90cm(Model 1125) Quattrode Lead, 4 electrode, 3/6mm, 90cm (Model 3159) Charger Accessory (Eon Mini LE) (Model 3720) 8-Channel Adapter, B, 60cm (Model 2326) Extension, 60cm (Model 3386) Proclaim 5 IPG (Medtronic header) (Model 3661) 8-Channel Adapter (Model 2311, 2316) MTS joining sleeve (Model 1627) Lead Instertion Tool (Model 1803) SCS EPG 2-Port Header (model 3042) Charging Apparel, pectoral (model 16760) Proclaim Plus 5 (Model 3670) Tripole 16C Lamitrode Lead (Model 3214) Eon Charger, Antenna (Model 3728) Charger Accessories Kit, lumbar (model 36000) Protege MRI patient programmer (Model 3853) Protege IPG (Model 3789) Patient manual and magnet (Model 3884) Power Supply, Portable Charger (Model 3713) Guide Wire for Percutaneous Leads (Model 1102) Eterna SCS IPG (model 32400) Lead and Extensions Insertion Tool (Model 1803) Extension, 30cm (Model 3383) Wide Spaced Quattrode Leads Epidural needle 4 (model 1114) Guardian Cranial Burr Hole Cover System Lead Extension Disposable Electrodes MTS Multiprogram Trial Stim System MTS MTS communication cable (Model 1273) Cinch Anchor Multi Lead Trial Cable (MLTC) RJ45 Adapter (Model 2002) SMK Radiofrequency Needle Guardian Cranial Burr Hole Cover System Octrode Quattrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2023-08-10
PMP	Dorsal Root Ganglion Stimulator For Pain Relief	Unknown	Class 3	N/A	2016-02-16
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2010-05-05
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2016-09-21
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-07-06
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2025-09-30
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2020-11-03
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2008-02-21
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Unknown	Class 3	N/A	2015-02-03
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2007-11-30
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2007-11-30
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2007-11-30
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2008-02-21
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2008-02-21
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2008-05-19
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2018-08-22
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2008-02-21
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-12-04
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2008-02-21
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2008-08-12
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2008-08-12
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2013-07-10
GZF	Stimulator, Peripheral Nerve, Implanted (Pain Relief)	Neurology	Class 2	882.5870	2013-07-10
GXD	Generator, Lesion, Radiofrequency	Neurology	Class 2	882.4400	2015-12-03
GXI	Probe, Radiofrequency Lesion	Neurology	Class 2	882.4725	2015-12-03
GXR	Cover, Burr Hole	Neurology	Class 2	882.5250	2016-07-25
GZB	Stimulator, Spinal-Cord, Implanted (Pain Relief)	Neurology	Class 2	882.5880	2008-05-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ABBOTT LABORATORIES

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004032053	Abbott S.r.l.	Milan Lombardy, IT
3011706799	Abbott Medical	Atlanta, GA, US
1628664	ABBOTT LABORATORIES	IRVING, TX, US
3023268435	Abbott Automation Solutions GmbH	Hamburg, DE
3001883144	St. Jude Medical Brasil Ltda.	Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K253907	ABBOTT MEDICAL	Disposable Radiofrequency Cannula	2026-04-16
K242841	ABBOTT MEDICAL	Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)	2025-05-27
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-0023-2018	St. Jude Medical, Inc.	3	Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663
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-0459-2026	Abbott Medical	3	Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Z-2265-2024	Abbott Medical	3	Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Z-2358-2024	Abbott Medical	3	Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Z-2359-2024	Abbott Medical	3	Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
Z-2360-2024	Abbott Medical	3	Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Z-2361-2024	Abbott Medical	3	Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
Z-2362-2024	Abbott Medical	3	Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Z-2363-2024	Abbott Medical	3	Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Z-2364-2024	Abbott Medical	3	Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
Z-2365-2024	Abbott Medical	3	Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
Z-2366-2024	Abbott Medical	3	Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
Z-2367-2024	Abbott Medical	3	Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, 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 1627487. Last updated year: 2026. Please use registration number 1627487 when referencing this establishment in official correspondence.