Data / Medical devices / United States / Abbott Medical
Abbott Medical: FDA-registered device maker in Plano, TX, United States, 25 510(k) clearances and 3 PMA approvals
Abbott Medical is registered with the FDA (registration 1627487) in Plano, TX, United States. It lists 14 device types. The FDA files 25 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 27, 2025. 22 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1627487
- Address
- 6901 Preston Rd, Plano, TX, United States, 75024
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- November 30, 2007
- Registered through
- 2026
- Brand names listed
- 4 Channel DBS Extension, 4 Channel DBS Lead, 6720, Brio LE Charger Accessory, 6722, BrioLE Charging System, 8-Channel Adapter, 8-Channel Adapter (Model 2311, 2316), 8-Channel Adapter, B, 10cm (Model 2321), 8-Channel Adapter, B, 60cm (Model 2326) and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| May 27, 2025 | K242841 | Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) | GXI | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| January 21, 2022 | K203293 | Abbott Medical Grounding Pad, model RF-DGP-IS | GXD | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| October 21, 2020 | K201610 | IonicRF Generator | GXD | Substantially Equivalent | ABBOTT MEDICAL | accessdata.fda.gov |
| July 20, 2018 | K181382 | GuardianTM Burr Hole Cover System | GXR | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| June 9, 2016 | K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | GXR | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| May 2, 2014 | K140272 | SWIFT-LOCK ANCHOR | GZB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| June 18, 2013 | K130545 | MULTI LEAD TRIAL CABLE | GZB | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| September 20, 2011 | K111576 | NT 2000 LESIONING GENERATOR | GXD | Substantially Equivalent | Neuro Therm, Inc. | accessdata.fda.gov |
| June 24, 2011 | K110609 | EPIDUCER LEAD DELIVERY SYSTEM | LHG | Substantially Equivalent | St Jude Medical | accessdata.fda.gov |
| December 23, 2009 | K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 | GZB | Substantially Equivalent | Advanced Neuromodulation Systems | accessdata.fda.gov |
| July 16, 2009 | K090955 | SMITH & NEPHEW RF CANNULATE | GXI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| January 28, 2009 | K083528 | SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 | GEI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| July 18, 2008 | K081208 | CINCH ANCHOR, MODEL 1194 | GZB | Substantially Equivalent | Advanced Neuromodulation Systems | accessdata.fda.gov |
| October 11, 2007 | K072462 | WIDE SPACED QUATTRODE LEADS | GZB | Substantially Equivalent | Advanced Neuromodulation Systems | accessdata.fda.gov |
| July 20, 2007 | K071300 | MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE | GXI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 11, 2007 | K070847 | TRIAL CABLE, 3009 | GZB | Substantially Equivalent | Advanced Neuromodulation Systems | accessdata.fda.gov |
| December 12, 2006 | K063080 | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS | GZB | Substantially Equivalent | Advanced Neuromodulation Systems | accessdata.fda.gov |
| January 23, 2006 | K052878 | NT-1000 | GXD | Substantially Equivalent | Neuro Therm, Inc. | accessdata.fda.gov |
| May 18, 2005 | K050922 | ANS SCS ACCESSORY KIT | GZB | Substantially Equivalent | Advanced Neuromodulation Systems | accessdata.fda.gov |
| October 26, 2004 | K042375 | SMK, CX, CXE, RCN | GXI | Substantially Equivalent | Technomed Europe | accessdata.fda.gov |
| January 30, 2004 | K033757 | MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM | GZB | Substantially Equivalent | Advanced Neuromodulation Systems | accessdata.fda.gov |
| October 6, 2003 | K032751 | MODIFICATION TO RENEW LEAD EXTENSION | GZB | Substantially Equivalent | Advanced Neuromodulation Systems | accessdata.fda.gov |
| September 6, 2001 | K011387 | NEUROTHERM, MODEL JK4 | GXI | Substantially Equivalent | Eurolink, LLC | accessdata.fda.gov |
| March 1, 2000 | K000073 | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA | GXI | Substantially Equivalent | Mercury Medical | accessdata.fda.gov |
| May 22, 1996 | K960728 | ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE) | GZB | Substantially Equivalent | Neuromed, Inc. | 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 |
|---|---|---|---|---|---|---|
| February 11, 2016 | P150004 | Axium Neurostimulator System | PMP | 92 | September 23, 2026 | accessdata.fda.gov |
| June 12, 2015 | P140009 | BRIO NEUROSTIMULATION SYSTEM | MHY | 135 | September 23, 2026 | accessdata.fda.gov |
| November 21, 2001 | P010032 | GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS | LGW | 244 | September 23, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 6, 2025 | 97754 | Class II | Ongoing | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400. These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC). | accessdata.fda.gov |
| May 22, 2024 | 94796 | Class II | Ongoing | Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only | Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy. | accessdata.fda.gov |
| May 16, 2024 | 94798 | Class II | Ongoing | Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only | The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. | accessdata.fda.gov |
| May 16, 2024 | 94747 | Class II | Ongoing | Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY | Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy. | accessdata.fda.gov |
| July 18, 2023 | 92688 | Class I | Ongoing | Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to on | Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). | accessdata.fda.gov |
| October 11, 2018 | 81461 | Class II | Terminated | St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY CE 0086 0123 St. Jude Medical Plano, TX St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 61 | The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium. | accessdata.fda.gov |
| March 9, 2018 | 79560 | Class II | Terminated | Proclaim DRG Implantable Pulse Generator, Model Number 3664 | The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Some complaints were also associated with transient over stimulation which created discomfort for the patients. | accessdata.fda.gov |
| September 12, 2017 | 78154 | Class II | Terminated | Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667 | Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations. | accessdata.fda.gov |
| June 2, 2017 | 77509 | Class II | Terminated | Proclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or lea | The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures. | accessdata.fda.gov |
| July 29, 2014 | 69025 | Class II | Terminated | Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation. | The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals. | accessdata.fda.gov |
| November 30, 2012 | 63947 | Class II | Terminated | Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger ( | There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is | accessdata.fda.gov |
| September 4, 2012 | 63154 | Class II | Terminated | 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 | Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the intern | accessdata.fda.gov |
| July 26, 2012 | 63109 | Class II | Terminated | Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain | St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant sit | accessdata.fda.gov |
| July 26, 2012 | 63108 | Class II | Terminated | Eon Mini - 3788 (IPG), 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, sur | As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adv | accessdata.fda.gov |
| March 28, 2012 | 61554 | Class II | Terminated | Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator. | Unintended Fluid ingress into the device header has been shown. | accessdata.fda.gov |
| December 19, 2011 | 61171 | Class II | Terminated | Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid | As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively. | accessdata.fda.gov |
| December 19, 2011 | 61151 | Class II | Terminated | Eon Mini Neurostimulation (IPG) System (Model 3788); The product 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 f | The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a sho | accessdata.fda.gov |
| May 24, 2011 | 56787 | Not yet classified | Terminated | Eon Mini Neurostimulation (IPG) System Model 3788 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 | Defective battery was identified as cause for reports of inability to communicate or recharge the product. | accessdata.fda.gov |
| April 23, 2010 | 55503 | Not yet classified | Terminated | Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilatera | Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability. | accessdata.fda.gov |
| February 22, 2010 | 55142 | Not yet classified | Terminated | Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the le | Directions For Use of product incorrectly stated lead compatibility information. | accessdata.fda.gov |
| June 2, 2009 | 57806 | Not yet classified | Terminated | Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Ge | Product programmed with unapproved software was distributed. | accessdata.fda.gov |
| December 22, 2006 | 53128 | Not yet classified | Terminated | Eon Rechargeable Implantable Pulse Generator (IPG) System | Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system. | accessdata.fda.gov |
Compare with other makers
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- All makers of Cover, Burr Hole
Updated September 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.