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)
Top companies in LYJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Cyberonics, Inc | 0 | 22 |
| LivaNova USA Inc | 0 | 15 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2025 | LivaNova USA, Inc. SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation.
Used for Vagus Nerve Stimulation (VNS). Open, Classified |
LYJ | None listed |
| Jan 31, 2025 | LivaNova 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 |
LYJ | None listed |
| Jan 30, 2025 | LivaNova 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 |
LYJ | None listed |
| Jan 30, 2025 | LivaNova 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 |
LYJ | None listed |
| Dec 2, 2021 | LivaNova 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 |
LYJ | None listed |
| Nov 12, 2020 | LivaNova 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 |
LYJ | None listed |
| Sep 28, 2020 | LivaNova USA Inc VNS Therapy AspireSR Generator Terminated |
LYJ | None listed |
| Feb 4, 2020 | LivaNova USA Inc VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. Open, Classified |
LYJ | None listed |
| Dec 20, 2019 | LivaNova USA Inc VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy Terminated |
LYJ | None listed |
| Aug 13, 2019 | LivaNova 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 |
LYJ | None listed |
| Nov 16, 2018 | LivaNova USA Inc VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly Open, Classified |
LYJ | None listed |
| Nov 16, 2018 | LivaNova 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 |
LYJ | None listed |
| Nov 16, 2018 | LivaNova 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 |
LYJ | None listed |
| Nov 16, 2018 | LivaNova 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 |
LYJ | None listed |
| Jan 24, 2018 | LivaNova USA Inc VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 Terminated |
LYJ | None listed |
| Dec 2, 2017 | Cyberonics, 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 |
LYJ | None listed |
| Jun 13, 2017 | Cyberonics, 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 |
LYJ | None listed |
| Jun 13, 2017 | Cyberonics, 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 |
LYJ | None listed |
| Jan 15, 2016 | Cyberonics, Inc VNS Therapy AspireSR Generator Model 106.
Indicated for use as an adjunctive therapy in reducing the frequency of seizures. Terminated |
LYJ | None listed |
| Jan 13, 2016 | Cyberonics, Inc Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106 Terminated |
LYJ | None listed |
| Nov 17, 2015 | Cyberonics, Inc Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106 Terminated |
LYJ | None listed |
| Apr 27, 2015 | Cyberonics, Inc VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC. Terminated |
LYJ | None listed |
| Dec 23, 2014 | Cyberonics, 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 |
LYJ | None listed |
| Nov 18, 2011 | Cyberonics, 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 |
LYJ | None listed |
| Oct 4, 2011 | Cyberonics, 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 |
LYJ | None listed |
| Oct 4, 2011 | Cyberonics, 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 |
LYJ | None listed |
| May 10, 2010 | Cyberonics, 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 |
LYJ | None listed |
| Jan 14, 2010 | Cyberonics, 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 |
LYJ | None listed |
| Nov 16, 2009 | Cyberonics, 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 |
LYJ | None listed |
| Apr 22, 2009 | Cyberonics, Inc Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable, multiprogrammable, vagus nerve stimulator. Terminated |
LYJ | None listed |
| Apr 22, 2009 | Cyberonics, Inc Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator. Terminated |
LYJ | None listed |
| Jan 29, 2008 | Cyberonics, 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 |
LYJ | None listed |
| Nov 28, 2007 | Cyberonics, Inc Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberonics, Inc., Houston, TX 77058. Terminated |
LYJ | None listed |
| Nov 28, 2007 | Cyberonics, Inc Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058. Terminated |
LYJ | None listed |
| Nov 28, 2007 | Cyberonics, Inc Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058. Terminated |
LYJ | None listed |
| Jan 25, 2007 | Cyberonics, 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 |
LYJ | None listed |
| Jan 25, 2007 | Cyberonics, 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 |
LYJ | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.