Product code LGW ยท Class 3
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
0510(k)s in 12 months (0 all time)
4recalls in 12 months (96 all time)
0recalls that name a 510(k)
Top companies in LGW
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neuromodulation | 0 | 36 |
| Abbott Medical | 0 | 19 |
| Boston Scientific Neuromodulation Corporation | 0 | 10 |
| Advanced Bionics Corp | 0 | 8 |
| Advanced Neuromodulation Systems | 0 | 8 |
| St. Jude Medical | 0 | 8 |
| QiG Group LLC | 0 | 3 |
| Medtronic Neurological | 0 | 2 |
| Nuvectra | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2019 | Boston Scientific Neuromodulation Corporation ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700.
2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Steri Terminated |
LGW | None listed |
| Jul 13, 2018 | Medtronic Neuromodulation Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models:
(a) 977A160
(b) 977A175
(c) 977A190
(d) 977A260
(e) 977A275
(f) 977A290
Product Usage:
The Medtronic Vectris lead kits contai Terminated |
LGW | None listed |
| Jul 13, 2018 | Medtronic Neuromodulation Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models:
(a) 977D160
(b) 977D260
Product Usage:
The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, Terminated |
LGW | None listed |
| Sep 12, 2017 | St. Jude Medical, Inc. Proclaim DRG Implantable Pulse Generator Model 3664 Terminated |
LGW | None listed |
| Sep 12, 2017 | St. Jude Medical, Inc. Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667 Terminated |
LGW | None listed |
| Jun 2, 2017 | St. Jude Medical, Inc. Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO
Product Usage:
The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one o Terminated |
LGW | None listed |
| Jun 2, 2017 | St. Jude Medical, Inc. 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 o Terminated |
LGW | None listed |
| Dec 17, 2016 | Nuvectra Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit;
Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit;
Algo Terminated |
LGW | None listed |
| Jun 7, 2016 | Medtronic Neuromodulation Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators.
Used to treat chronic, intractable pain of the trunk and/or limbs-including unilat Terminated |
LGW | None listed |
| May 3, 2016 | Nuvectra Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1 Terminated |
LGW | None listed |
| Mar 18, 2016 | QiG Group LLC Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400 Terminated |
LGW | None listed |
| Mar 18, 2016 | QiG Group LLC Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel) Terminated |
LGW | None listed |
| Mar 18, 2016 | QiG Group LLC Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel) Terminated |
LGW | None listed |
| Jan 11, 2016 | Medtronic Neuromodulation Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-i Terminated |
LGW | None listed |
| Jun 26, 2015 | Medtronic Neuromodulation The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connecte Terminated |
LGW | None listed |
| Apr 29, 2014 | Medtronic Neuromodulation Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including the external neurostimulators which are associated with software application run on the NVision Clinician Programmer and use Terminated |
LGW | None listed |
| Apr 29, 2014 | Medtronic Neuromodulation Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (9770 Terminated |
LGW | None listed |
| Nov 14, 2013 | Medtronic Neuromodulation Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Terminated |
LGW | None listed |
| Oct 31, 2013 | Medtronic Neuromodulation Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
Medtronic Activa RC and Activa PC Deep Brain Stimulators are ind Terminated |
LGW | None listed |
| Oct 31, 2013 | Medtronic Neuromodulation Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Medtronic implantable neurostimulation system is indicat Terminated |
LGW | None listed |
| Jul 31, 2013 | St. Jude Medical 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 follo Terminated |
LGW | None listed |
| Jul 22, 2013 | St. Jude Medical 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:
Terminated |
LGW | None listed |
| Jul 16, 2013 | St. Jude Medical Eon Mini - 3721 (Charger).
Product Usage:
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 assoc Terminated |
LGW | None listed |
| Jul 16, 2013 | St. Jude Medical 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 unilat Terminated |
LGW | 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 |
| Apr 19, 2012 | Advanced Bionics Corporation OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305
The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk 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 16, 2010 | Boston Scientific Neuromodulation Corporation Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4 Terminated |
LGW | None listed |
| Dec 11, 2009 | Medtronic Neuromodulation Medtronic Accessory Kit , Titan Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are STERILE., Medtronic, Inc, Minneapolis, MN 55432-5604 Terminated |
LGW | None listed |
| Nov 10, 2009 | Advanced Neuromodulation Systems, Inc Eon Rechargeable Implantable Pulse Generator (IPG) System Terminated |
LGW | None listed |
| Oct 31, 2008 | Advanced Bionics Corp Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply (1) Adhe Terminated |
LGW | None listed |
| Sep 20, 2008 | Medtronic Neuromodulation Medtronic Patient programmer, model 37742. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable de Terminated |
LGW | None listed |
| Sep 16, 2008 | Medtronic Neuromodulation Medtronic 1x8 3777-xx, Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide, Rx Only, Terminated |
LGW | None listed |
| Feb 27, 2008 | Advanced Bionics Corp Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number SC-1100 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342 Terminated |
LGW | None listed |
| Feb 27, 2008 | Advanced Bionics Corp Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342 Terminated |
LGW | None listed |
| Oct 12, 2007 | Advanced Bionics Corp Precision Implantable Pulse Generator (IPG), Model Number SC-110 Terminated |
LGW | None listed |
| Mar 31, 2007 | Advanced Bionics Corp The Precision Implantable Pulse Generator, Model Number SC-1110 Terminated |
LGW | None listed |
| Jan 10, 2007 | Advanced Bionics Corporation Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70. Terminated |
LGW | None listed |
| Sep 29, 2006 | Medtronic Neurological Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432 Terminated |
LGW | None listed |
| Sep 29, 2006 | Medtronic Neurological Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604. Terminated |
LGW | None listed |
| Jan 15, 2005 | Advanced Bionics Corporation Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System Terminated |
LGW | None listed |
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