Stimulator, Autonomic Nerve, Implanted For Epilepsy
Basic Information
- Device Name
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Trade Name
- VNS Therapy System
- PMA Number
- P970003
- Supplement Number
- S245
- Device Class
- FDA Class 3
- Product Code
- LYJ
- Generic Name
- STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 14, 2024
- Date Received
- October 15, 2024
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
VNS Therapy Physicians 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy | FDA class 3 | Unknown |