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PMA P970003S248

Device
VNS Therapy System
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S248
Product code
LYJ
Decision date
2025-09-05
Classification
Neurology
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement
Approval for:1. VNS Therapy Epilepsy Physician’s Manuals:Update to create a new “Management of Depression as a Comorbidity” section to inform physicians that depression is a common comorbidity for epilepsy patients and to follow standard medical practice for follow up with these patients and monitoring of their depressive symptoms.• Document 26-0011-0100 (Epilepsy Manual; Appendix 1, page 117) New Section added to the Post-Implant Management Chapter: Follow-up Visits: Long-Term Follow Up Section- 7.1.2.2.1 Management of Depression as a Comorbidity:Depression is a common comorbidity in patients with epilepsy. In accordance with standard medical practice, patients with a current or prior diagnosis of depression should be advised to report any new or worsening depressive symptoms, including suicidal ideation.2. VNS Therapy Epilepsy Patient Guide:Update to create a new “Patients with Depression” section to inform patients that may also have depression to follow up with their doctor if they have new or worsening depressive symptoms.• Document 26-0011-1600 (Epilepsy Patient Guide; Appendix 2, page 19). New section added to the Follow Up After Surgery Chapter: After Treatment Begins Section- 6.4.3 Patients with Depression:Some people with epilepsy also have depression. If you have depression now or had it in the past, it is important to monitor your mood and mental health. Contact your doctor if you notice any new or worsening depressive symptoms, including suicidal thoughts.

Current openFDA PMA Record#

Device
VNS Therapy System
Applicant
LivaNova USA, Inc.
PMA number
P970003
Supplement
S248
Product code
LYJ
Generic name
Stimulator, autonomic nerve, implanted for epilepsy
Decision date
2025-09-05
Decision code
APPR
Date received
2025-08-06
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for:1. VNS Therapy Epilepsy Physician’s Manuals:Update to create a new “Management of Depression as a Comorbidity” section to inform physicians that depression is a common comorbidity for epilepsy patients and to follow standard medical practice for follow up with these patients and monitoring of their depressive symptoms.• Document 26-0011-0100 (Epilepsy Manual; Appendix 1, page 117) New Section added to the Post-Implant Management Chapter: Follow-up Visits: Long-Term Follow Up Section- 7.1.2.2.1 Management of Depression as a Comorbidity:Depression is a common comorbidity in patients with epilepsy. In accordance with standard medical practice, patients with a current or prior diagnosis of depression should be advised to report any new or worsening depressive symptoms, including suicidal ideation.2. VNS Therapy Epilepsy Patient Guide:Update to create a new “Patients with Depression” section to inform patients that may also have depression to follow up with their doctor if they have new or worsening depressive symptoms.• Document 26-0011-1600 (Epilepsy Patient Guide; Appendix 2, page 19). New section added to the Follow Up After Surgery Chapter: After Treatment Begins Section- 6.4.3 Patients with Depression:Some people with epilepsy also have depression. If you have depression now or had it in the past, it is important to monitor your mood and mental health. Contact your doctor if you notice any new or worsening depressive symptoms, including suicidal thoughts.