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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVNS Therapy System
Generic NameStimulator, autonomic nerve, implanted for epilepsy
ApplicantLivaNova USA, Inc.
100 Cyberonics Blvd.
Houston, TX 77058
PMA NumberP970003
Supplement NumberS248
Date Received08/06/2025
Decision Date09/05/2025
Product Codes MUZ LYJ 
Advisory Committee Neurology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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