PMA P970003S245

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S245
Product code: LYJ
Decision date: 2024-11-14
Classification: Neurology
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Approval order statement: VNS Therapy Physician’s Manuals (Epilepsy and Depression): Update to the Warnings, Device Diagnostics, and General Troubleshooting sections to add information related to a Potential Loss of Function due to a stuck-closed reed switch. Additional update to the technical language to refer to the magnetic sensor more generally instead of specifying a “reed switch” to allow other technologies to be used without requiring additional labeling updates.• VNS Therapy Patient Guides (Epilepsy and Depression): Updates to the General Warnings, “How the Magnet Works”, General Malfunction, and Frequently Asked Questions to add information related to device malfunctions, and specifically potentially malfunction of the sensor in the M1000 or M1000-D device. Additionally, updates to remove unnecessary technical information about the “reed switch” and instead only provide information about the functions of the magnet.

Current openFDA PMA Record#

Device: VNS Therapy System
Applicant: LivaNova USA, Inc.
PMA number: P970003
Supplement: S245
Product code: LYJ
Generic name: Stimulator, autonomic nerve, implanted for epilepsy
Decision date: 2024-11-14
Decision code: APPR
Date received: 2024-10-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: VNS Therapy Physician’s Manuals (Epilepsy and Depression): Update to the Warnings, Device Diagnostics, and General Troubleshooting sections to add information related to a Potential Loss of Function due to a stuck-closed reed switch. Additional update to the technical language to refer to the magnetic sensor more generally instead of specifying a “reed switch” to allow other technologies to be used without requiring additional labeling updates.• VNS Therapy Patient Guides (Epilepsy and Depression): Updates to the General Warnings, “How the Magnet Works”, General Malfunction, and Frequently Asked Questions to add information related to device malfunctions, and specifically potentially malfunction of the sensor in the M1000 or M1000-D device. Additionally, updates to remove unnecessary technical information about the “reed switch” and instead only provide information about the functions of the magnet.