ClearanceBrief
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)
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Top companies in LGW

DateFirm and productCodeLinked 510(k)
Apr 24, 2019Boston 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
LGWNone listed
Jul 13, 2018Medtronic 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
LGWNone listed
Jul 13, 2018Medtronic 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
LGWNone listed
Sep 12, 2017St. Jude Medical, Inc.
Proclaim DRG Implantable Pulse Generator Model 3664
Terminated
LGWNone listed
Sep 12, 2017St. Jude Medical, Inc.
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Terminated
LGWNone listed
Jun 2, 2017St. 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
LGWNone listed
Jun 2, 2017St. 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
LGWNone listed
Dec 17, 2016Nuvectra
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
LGWNone listed
Jun 7, 2016Medtronic 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
LGWNone listed
May 3, 2016Nuvectra
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
LGWNone listed
Mar 18, 2016QiG Group LLC
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Terminated
LGWNone listed
Mar 18, 2016QiG Group LLC
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)
Terminated
LGWNone listed
Mar 18, 2016QiG Group LLC
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
Terminated
LGWNone listed
Jan 11, 2016Medtronic 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
LGWNone listed
Jun 26, 2015Medtronic 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
LGWNone listed
Apr 29, 2014Medtronic 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
LGWNone listed
Apr 29, 2014Medtronic Neuromodulation
Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced SureScan MRI, (9770
Terminated
LGWNone listed
Nov 14, 2013Medtronic Neuromodulation
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Terminated
LGWNone listed
Oct 31, 2013Medtronic 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
LGWNone listed
Oct 31, 2013Medtronic Neuromodulation
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicat
Terminated
LGWNone listed
Jul 31, 2013St. 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
LGWNone listed
Jul 22, 2013St. 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
LGWNone listed
Jul 16, 2013St. 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
LGWNone listed
Jul 16, 2013St. 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
LGWNone listed
Oct 9, 2012Advanced 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
LGWNone listed
Aug 28, 2012Advanced 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
LGWNone listed
Aug 28, 2012Advanced 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
LGWNone listed
Jul 10, 2012Advanced 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
LGWNone listed
Apr 19, 2012Advanced 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
LGWNone listed
Aug 30, 2011Advanced 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
LGWNone listed
Jun 22, 2011Advanced 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
LGWNone listed
May 13, 2010Advanced 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
LGWNone listed
Apr 16, 2010Boston Scientific Neuromodulation Corporation
Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
Terminated
LGWNone listed
Dec 11, 2009Medtronic 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
LGWNone listed
Nov 10, 2009Advanced Neuromodulation Systems, Inc
Eon Rechargeable Implantable Pulse Generator (IPG) System
Terminated
LGWNone listed
Oct 31, 2008Advanced 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
LGWNone listed
Sep 20, 2008Medtronic 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
LGWNone listed
Sep 16, 2008Medtronic 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
LGWNone listed
Feb 27, 2008Advanced 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
LGWNone listed
Feb 27, 2008Advanced 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
LGWNone listed
Oct 12, 2007Advanced Bionics Corp
Precision Implantable Pulse Generator (IPG), Model Number SC-110
Terminated
LGWNone listed
Mar 31, 2007Advanced Bionics Corp
The Precision Implantable Pulse Generator, Model Number SC-1110
Terminated
LGWNone listed
Jan 10, 2007Advanced 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
LGWNone listed
Sep 29, 2006Medtronic 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
LGWNone listed
Sep 29, 2006Medtronic 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
LGWNone listed
Jan 15, 2005Advanced Bionics Corporation
Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
Terminated
LGWNone listed

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