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Sign in to claim this brandAdvanced Neuromodulation Systems
US
Last updated May 23, 2026
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Catalogue (69)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Lamitrode® | 3244 | FDA UDI | Class III | Active |
| Lamitrode® | 3288 | FDA UDI | Class III | Active |
| Lamitrode® | 3268 | FDA UDI | Class III | Unknown |
| Sjm™ | 3701 | FDA UDI | Class III | Active |
| Proclaim™ | 3884 | FDA UDI | Class III | Active |
| Eon Mini™ | 3719 | FDA UDI | Class III | Unknown |
| Quattrode® | 3159 | FDA UDI | Class III | Unknown |
| Penta™ | 3228 | FDA UDI | Class III | Active |
| SlimTip™ | MN10350-90A | FDA UDI | Class III | Active |
| Lamitrode® | 3246 | FDA UDI | Class III | Active |
| Quattrode® | 3153 | FDA UDI | Class III | Active |
| Octrode® | 3186 | FDA UDI | Class III | Active |
| NeuroSphere™ | 3876 | FDA UDI | Class III | Active |
| Lamitrode® | 3266 | FDA UDI | Class III | Unknown |
| Eon Mini™ | 3721 | FDA UDI | Class III | Active |
| Lamitrode® | 3243 | FDA UDI | Class III | Unknown |
| Lamitrode® | 3262 | FDA UDI | Class III | Active |
| Eon Mini™ | 3720 | FDA UDI | Class III | Active |
| Octrode® | 3183 | FDA UDI | Class III | Active |
| Quattrode® | 3141 | FDA UDI | Class III | Unknown |
| Exclaim™ | 3224 | FDA UDI | Class III | Active |
| Lamitrode Tripole™ | 3219 | FDA UDI | Class III | Active |
| Quattrode™ | 3066 | FDA UDI | Class II | Active |
| Sjm™ | 3870 | FDA UDI | Class III | Unknown |
| Eon Mini™ | 3722 | FDA UDI | Class III | Active |
| SlimTip™ | MN10450-90A | FDA UDI | Class III | Active |
| Quattrode® | 3143 | FDA UDI | Class III | Active |
| Quattrode® | 3161 | FDA UDI | Class II | Unknown |
| Liberta RC™ | 62400 | FDA UDI | Class III | Active |
| Lamitrode® | 3240 | FDA UDI | Class III | Active |
| Sjm™ | 3871 | FDA UDI | Class III | Unknown |
| Lamitrode® | 3286 | FDA UDI | Class III | Active |
| Eon™ | 3716 | FDA UDI | Class III | Unknown |
| Quattrode® | 3146 | FDA UDI | Class III | Active |
| Mts™ | 1273 | FDA UDI | Class III | Active |
| Lamitrode Tripole™ | 3214 | FDA UDI | Class III | Active |
| Sjm™ | 1115 | FDA UDI | Class III | Unknown |
| Lamitrode® | 3283 | FDA UDI | Class III | Unknown |
| SlimTip™ | MN10350-50A | FDA UDI | Class III | Active |
| Proclaim™ | 7884 | FDA UDI | Class III | Active |
| SlimTip™ | MN10450-50A | FDA UDI | Class III | Active |
| Eon™ | 3851 | FDA UDI | Class III | Active |
| Rapid Programmer | K040609 | FDA 510(k) | Class II | Active |
| Wide Spaced Quattrode Leads | K072462 | FDA 510(k) | Class II | Active |
| Ans Scs Accessory Kit | K050922 | FDA 510(k) | Class II | Active |
| Rapid Progeammer 3.0 | K052374 | FDA 510(k) | Class II | Active |
| Rapid Programmer, Version 3.3.0 | K091993 | FDA 510(k) | Class II | Active |
| A127 Lead Extension | K030461 | FDA 510(k) | Class II | Active |
| Axxess Butterfly Anchor | K052418 | FDA 510(k) | Class II | Active |
| Renew Receiver | K992946 | FDA 510(k) | Class II | Active |
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Z-0025-2013 | — | terminated | 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 internal microcontroller board. |
| Mar 28, 2012 | Z-0894-2013 | — | terminated | Unintended Fluid ingress into the device header has been shown. |
| Dec 19, 2011 | Z-2280-2012 | — | terminated | 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. |
| Dec 19, 2011 | Z-1983-2012 | — | terminated | 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 short, and therefore, prematurely depletin |
| Dec 19, 2011 | Z-2281-2012 | — | terminated | 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. |
| May 24, 2011 | Z-2607-2011 | — | terminated | Defective battery was identified as cause for reports of inability to communicate or recharge the product. |
| Apr 23, 2010 | Z-1599-2010 | — | terminated | Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability. |
| Feb 22, 2010 | Z-1425-2010 | — | terminated | Directions For Use of product incorrectly stated lead compatibility information. |
| Jun 2, 2009 | Z-3091-2011 | — | terminated | Product programmed with unapproved software was distributed. |
| Dec 22, 2006 | Z-0170-2010 | — | terminated | Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system. |