BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Abbott Medical

    Reg #: 1627487 · FEI: 1627487 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    170
    Establishment Types
    3
    Classifications
    13

    Registration Details

    Registration Name
    Abbott Medical
    Registration Number
    1627487
    FEI Number
    1627487
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6901 Preston Rd
    City
    PLANO
    State
    TX
    ZIP
    75024
    Country
    US

    Regulatory Submissions

    510(k) Number
    K071300
    PMA Number
    P150004

    Owner / Operator

    Firm Name
    ABBOTT LABORATORIES
    Operator Number
    1415939
    Address
    100 ABBOTT PARK RD., D-03Q3, AP52-1
    City
    Abbott Park
    State
    IL
    Postal Code
    60064
    Country
    US

    Products

    Device Name Product Code
    Probe, Radiofrequency Lesion GXI
    Dorsal Root Ganglion Stimulator For Pain Relief PMP
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Instrument, Surgical, Non-Powered HAO
    Generator, Lesion, Radiofrequency GXD
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor MHY
    Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy QRB
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief LGW
    Stimulator, Peripheral Nerve, Implanted (Pain Relief) GZF
    Cover, Burr Hole GXR
    Stimulator, Electrical, Implanted, For Essential Tremor PJS
    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms NHL
    Electrode, Spinal Epidural LHG

    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 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 Octrode™ Quattrode™ Classic Radiofrequency Cannula Charger Kit - Pectoral (model 66000) 4 Channel DBS Extension St. Jude Medical Infinity DBS System St. Jude Medical Infinity™ DBS System 8CH Directional Lead Infinity™ 5 IPG, MDT Header 4 Channel DBS Lead Brio Patient Programmer Infinity™ 7 IPG, MDT Header Infinity™ 7 IPG DBS Charging System (model 66700) Liberta RC™ DBS IPG (model 62400) St. Jude Medical Infinity™ DBS System 8CH Flex Extn St. Jude Medical Infinity™ DBS System 4CH Extn Infinity™ 5 IPG Brio LE Charging System 8-Channel Adapter Brio Implantable Pulse Generator Brio LE Charger Accessory St. Jude Medical Deep Brain Stimulator External Pulse Generator St. Jude Medical Infinity™ DBS System 4CH Lead St. Jude Medical Infinity™ DBS System 4CH Flex Extn Exclaim 8 Lamitrode Lead Epiducer Lead Delivery System Swift-Lock™ Anchor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Device in the United States for Export Only