ClearanceBrief
Product code LYJ ยท Class 3

Stimulator, Autonomic Nerve, Implanted For Epilepsy

0510(k)s in 12 months (0 all time)
0recalls in 12 months (37 all time)
0recalls that name a 510(k)
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Top companies in LYJ

Company510(k)sRecalls
Cyberonics, Inc022
LivaNova USA Inc015
DateFirm and productCodeLinked 510(k)
Jan 31, 2025LivaNova USA, Inc.
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Open, Classified
LYJNone listed
Jan 31, 2025LivaNova USA, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Open, Classified
LYJNone listed
Jan 30, 2025LivaNova USA, Inc.
Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Ne
Open, Classified
LYJNone listed
Jan 30, 2025LivaNova USA, Inc.
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimula
Open, Classified
LYJNone listed
Dec 2, 2021LivaNova USA, Inc.
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diame
Terminated
LYJNone listed
Nov 12, 2020LivaNova USA Inc
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depress
Terminated
LYJNone listed
Sep 28, 2020LivaNova USA Inc
VNS Therapy AspireSR Generator
Terminated
LYJNone listed
Feb 4, 2020LivaNova USA Inc
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
Open, Classified
LYJNone listed
Dec 20, 2019LivaNova USA Inc
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Terminated
LYJNone listed
Aug 13, 2019LivaNova USA Inc
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-50
Terminated
LYJNone listed
Nov 16, 2018LivaNova USA Inc
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Open, Classified
LYJNone listed
Nov 16, 2018LivaNova USA Inc
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Terminated
LYJNone listed
Nov 16, 2018LivaNova USA Inc
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Terminated
LYJNone listed
Nov 16, 2018LivaNova USA Inc
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. Th
Open, Classified
LYJNone listed
Jan 24, 2018LivaNova USA Inc
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Terminated
LYJNone listed
Dec 2, 2017Cyberonics, Inc
VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive ther
Terminated
LYJNone listed
Jun 13, 2017Cyberonics, Inc
VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use
Terminated
LYJNone listed
Jun 13, 2017Cyberonics, Inc
VNS Therapy AspireHC Generator, VNS Therapy AspireSR Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use
Terminated
LYJNone listed
Jan 15, 2016Cyberonics, Inc
VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
Terminated
LYJNone listed
Jan 13, 2016Cyberonics, Inc
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Terminated
LYJNone listed
Nov 17, 2015Cyberonics, Inc
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Terminated
LYJNone listed
Apr 27, 2015Cyberonics, Inc
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Terminated
LYJNone listed
Dec 23, 2014Cyberonics, Inc
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system use
Terminated
LYJNone listed
Nov 18, 2011Cyberonics, Inc
VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 For implantation in humans to treat Epilepsy and Depression.
Terminated
LYJNone listed
Oct 4, 2011Cyberonics, Inc
Model 104 VNS Therapy Demipulse Duo Generator Cyberonics, Inc. Houston, Texas, Model 104 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling m
Terminated
LYJNone listed
Oct 4, 2011Cyberonics, Inc
VNS Therapy Demipulse Model 103 Generator Cyberonics, Inc. Houston, Texas, Model 103 Generators are provided in a sterile single use packages as part of the VNS Therapy System. Product labeling may b
Terminated
LYJNone listed
May 10, 2010Cyberonics, Inc
VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104 VNS Therapy Programming System, Model 250 Version 7.0 and 7.1 Software
Terminated
LYJNone listed
Jan 14, 2010Cyberonics, Inc
VNS Therapy Demipulse Generator, Model 103 and VNS Therapy Demipulse Duo Generator, Model 104. The Cyberonics VNS Therapy system consists of an implantable VNS Therapy Generator, the VNS Therapy Le
Terminated
LYJNone listed
Nov 16, 2009Cyberonics, Inc
Cyberonics VNS Therapy Programming M250 Programming System, model number 250, version 4.6, 6.1, 7.0 and 7.1. The Model 250 Handheld software is provided on flashcards packaged in software envelopes o
Terminated
LYJNone listed
Apr 22, 2009Cyberonics, Inc
Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator.
Terminated
LYJNone listed
Apr 22, 2009Cyberonics, Inc
Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator.
Terminated
LYJNone listed
Jan 29, 2008Cyberonics, Inc
Cyberonics, VNS Therapy System Model 250 Handheld programming system using Dell x5 handheld and preprogrammed with software v7.1 and higher; manufactured by Cyberonics, Inc., Houston, TX.
Terminated
LYJNone listed
Nov 28, 2007Cyberonics, Inc
Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberonics, Inc., Houston, TX 77058.
Terminated
LYJNone listed
Nov 28, 2007Cyberonics, Inc
Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.
Terminated
LYJNone listed
Nov 28, 2007Cyberonics, Inc
Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.
Terminated
LYJNone listed
Jan 25, 2007Cyberonics, Inc
Handhelds-Cyberonics VNS Therapy System, Model 250-''Handhelds'' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
Terminated
LYJNone listed
Jan 25, 2007Cyberonics, Inc
Cyberonics VNS Therapy System, Model 250-''HAND HELD'' programming software v6.1, v6.1.7, v7.0 and v7.1.3; manufactured by Cyberonics, Inc., Houston, TX.
Terminated
LYJNone listed

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