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    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.

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc·February 5, 2020

    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.

    FDA Enforcement
    Class II ·Terminated·LivaNova USA Inc·February 5, 2020

    VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·May 6, 2015

    Cyberonics Neuro Cyberonics Prosthesis System NCP Bipolar Lead, Model #300; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·August 2, 2007

    Cyberonics VNS Therapy Perrennia Lead, Model #303; Sterile, Single use only; distributed by Cyberonics, Inc., Houston, TX 77058.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·August 2, 2007

    Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·August 2, 2007

    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.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·October 17, 2006

    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.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·August 12, 2011

    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.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·October 17, 2006

    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.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    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.

    FDA Recall
    Terminated ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    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.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·October 25, 2007

    VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·March 6, 2015

    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 be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·May 6, 2011

    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 may be found at http://us.cyberonics.com/en/vns-therapy-for-epilepsy/healthcare-professionals/vns-therapy/manuals-page. Product Usage: The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications and for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.

    FDA Recall
    Terminated ·Cyberonics, Inc·Product code LYJ·May 6, 2011

    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 used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·December 31, 2014

    Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·November 25, 2015

    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 as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·August 23, 2017

    Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·January 27, 2016

    VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

    FDA Enforcement
    Class II ·Terminated·Cyberonics, Inc·January 27, 2016