Company ยท US
Advanced Neuromodulation Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2009. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2009 | K092371 | SWIFT-LOCK ANCHOR, MODEL 1192 Advanced Neuromodulation Systems | GZB |
| Jun 2, 2009 | K090907 | PENTA LEAD KITS, MODELS: 3227-3234 Advanced Neuromodulation Systems | GZB |
| Jul 18, 2008 | K081208 | CINCH ANCHOR, MODEL 1194 Advanced Neuromodulation Systems | GZB |
| Oct 11, 2007 | K072462 | WIDE SPACED QUATTRODE LEADS Advanced Neuromodulation Systems | GZB |
| Apr 11, 2007 | K070847 | TRIAL CABLE, 3009 Advanced Neuromodulation Systems | GZB |
| Dec 12, 2006 | K063080 | TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS Advanced Neuromodulation Systems | GZB |
| Dec 15, 2005 | K053250 | ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT Advanced Neuromodulation Systems | GZB |
| Nov 22, 2005 | K052374 | RAPID PROGEAMMER 3.0 Advanced Neuromodulation Systems | GZB |
| Sep 26, 2005 | K052418 | AXXESS BUTTERFLY ANCHOR Advanced Neuromodulation Systems | GZB |
| May 18, 2005 | K050922 | ANS SCS ACCESSORY KIT Advanced Neuromodulation Systems | GZB |
| Apr 21, 2005 | K050633 | TRIAL CABLE RETENTION CLIP Advanced Neuromodulation Systems | GZB |
| Mar 25, 2004 | K040609 | RAPID PROGRAMMER Advanced Neuromodulation Systems | GZB |
| Jan 30, 2004 | K033757 | MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM Advanced Neuromodulation Systems | GZB |
| Dec 4, 2003 | K033429 | LAMITRODE SPINAL CORD STIMULATION LEADS Advanced Neuromodulation Systems | GZB |
| Oct 6, 2003 | K032751 | MODIFICATION TO RENEW LEAD EXTENSION Advanced Neuromodulation Systems | GZB |
| Oct 3, 2003 | K032349 | PLACER Advanced Neuromodulation Systems | GZB |
| Oct 3, 2003 | K032034 | ANS AXXESS PERCUTANEOUS LEAD Advanced Neuromodulation Systems | GZB |
| Apr 24, 2003 | K030461 | A127 LEAD EXTENSION Advanced Neuromodulation Systems | GZB |
| Mar 28, 2003 | K030674 | MODIFICATION TO AXXESS SPINAL CORD STIMULATION LEAD Advanced Neuromodulation Systems | GZB |
| Mar 11, 2003 | K030118 | RAPID PROGRAMMAR Advanced Neuromodulation Systems | GZB |
| Jun 6, 2002 | K021518 | PAINDOC Advanced Neuromodulation Systems | GZB |
| Jan 19, 2001 | K000852 | RENEW NEUROSTIMULATION SYSTEM Advanced Neuromodulation Systems | GZF |
| Sep 24, 1999 | K992946 | RENEW RECEIVER Advanced Neuromodulation Systems | GZB |
| Jun 24, 1999 | K991784 | RENEW LEAD EXTENSION Advanced Neuromodulation Systems | GZB |
| Jun 3, 1999 | K990469 | LAMITRODE LEADS Advanced Neuromodulation Systems | GZB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2013 | Advanced Neuromodulation Systems Inc. Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator. Terminated |
MHY | None listed |
| Oct 9, 2012 | Advanced Neuromodulation Systems Inc. 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 powere Terminated |
LGW | None listed |
| Aug 28, 2012 | Advanced Neuromodulation Systems Inc. The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads.
Product U Terminated |
LGW | None listed |
| Aug 28, 2012 | Advanced Neuromodulation Systems Inc. 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 Terminated |
LGW | None listed |
| Jul 10, 2012 | Advanced Neuromodulation Systems Inc. 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 Terminated |
LGW | None listed |
| Aug 30, 2011 | Advanced Neuromodulation Systems 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 gene Terminated |
LGW | None listed |
| Jun 22, 2011 | Advanced Neuromodulation Systems Inc. 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 associat Terminated |
LGW | None listed |
| May 13, 2010 | Advanced Neuromodulation Systems, Inc 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 Terminated |
LGW | None listed |
| Apr 21, 2010 | Advanced Neuromodulation Systems, Inc 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, functio Terminated |
GZB | K092371 |
| Nov 10, 2009 | Advanced Neuromodulation Systems, Inc Eon Rechargeable Implantable Pulse Generator (IPG) System Terminated |
LGW | None listed |