Advanced Neuromodulation Systems
Medical device manufacturer in Plano, TX.
25510(k) clearances
0PMA approvals
10recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K092371 | Swift-Lock Anchor, Model 1192GZB · Traditional | 12/23/2009SE |
| K090907 | Penta Lead Kits, Models: 3227-3234GZB · Traditional | 06/02/2009SE |
| K081208 | Cinch Anchor, Model 1194GZB · Traditional | 07/18/2008SE |
| K072462 | Wide Spaced Quattrode LeadsGZB · Special | 10/11/2007SE |
| K070847 | Trial Cable, 3009GZB · Special | 04/11/2007SE |
| K063080 | Tripole 8C and 16C and Exclaim 8 Lamitrode Series LeadsGZB · Special | 12/12/2006SE |
| K053250 | Ans 90 CM and 110 CM (3100 and 3200 Series) Lead KitGZB · Special | 12/15/2005SE |
| K052374 | Rapid Progeammer 3.0GZB · Traditional | 11/22/2005SE |
| K052418 | Axxess Butterfly AnchorGZB · Special | 09/26/2005SE |
| K050922 | Ans SCS Accessory KitGZB · Special | 05/18/2005SE |
| K050633 | Trial Cable Retention ClipGZB · Special | 04/21/2005SE |
| K040609 | Rapid ProgrammerGZB · Special | 03/25/2004SE |
| K033757 | MTS Multiprogram Trial Stimulator SystemGZB · Traditional | 01/30/2004SE |
| K033429 | Lamitrode Spinal Cord Stimulation LeadsGZB · Special | 12/04/2003SE |
| K032751 | Modification to Renew Lead ExtensionGZB · Special | 10/06/2003SE |
| K032349 | PlacerGZB · Traditional | 10/03/2003SE |
| K032034 | Ans Axxess Percutaneous LeadGZB · Traditional | 10/03/2003SE |
| K030461 | A127 Lead ExtensionGZB · Traditional | 04/24/2003SE |
| K030674 | Modification to Axxess Spinal Cord Stimulation LeadGZB · Special | 03/28/2003SE |
| K030118 | Rapid ProgrammarGZB · Traditional | 03/11/2003SE |
| K021518 | PaindocGZB · Special | 06/06/2002SE |
| K000852 | Renew Neurostimulation SystemGZF · Traditional | 01/19/2001SE |
| K992946 | Renew ReceiverGZB · Special | 09/24/1999SE |
| K991784 | Renew Lead ExtensionGZB · Special | 06/24/1999SE |
| K990469 | Lamitrode LeadsGZB · Traditional | 06/03/1999SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0025-2013 Class II | The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable…Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that… | 09/04/2012Terminated |
| Z-0894-2013 Class II | Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or…Unintended Fluid ingress into the device header has been shown. | 03/28/2012Terminated |
| Z-2281-2012 Class II | The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable…As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the… | 12/19/2011Terminated |
| Z-2280-2012 Class II | Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to…As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the… | 12/19/2011Terminated |
| Z-1983-2012 Class II | Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid…The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge… | 12/19/2011Terminated |
| Z-2607-2011 | Eon Mini Neurostimulation (IPG) System Model 3788 System is indicated as an aid in the…Defective battery was identified as cause for reports of inability to communicate or recharge the product. | 05/24/2011Terminated |
| Z-1599-2010 | Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc.…Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or… | 04/23/2010Terminated |
| Z-1425-2010 | Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude…Directions For Use of product incorrectly stated lead compatibility information. | 02/22/2010Terminated |
| Z-3091-2011 | Software version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for…Product programmed with unapproved software was distributed. | 06/02/2009Terminated |
| Z-0170-2010 | Eon Rechargeable Implantable Pulse Generator (IPG) SystemProduct's external charging system on occasion was failing to communicate with the Implantable Pulse… | 12/22/2006Terminated |