Neurocybernetic Prosthesis (ncp) Programming Wand
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- VNS THERAPY SYSTEM FDA PMA
- Generic Name
- Stimulator, autonomic nerve, implanted for epilepsy FDA PMA
Identifiers
- PMA Number
- P970003 FDA PMA
- FDA Product Code
- LYJ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Model 201 NCP Programming Wand is an implantable programmer designed for use with the NeuroCybernetic Prosthesis (NCP) System. It functions as an autonomic nerve stimulator, specifically for vagus nerve stimulation, and is intended for programming and communication with implanted devices such as the Model 100 NCP Generator.
This device is powered by a single 9-volt battery and transmits signals to and from a computer via a cable connected to a standard DB9 plug. It is supplied as part of the NCP System and is regulated under FDA Premarket Approval (PMA) P970003. The wand is intended for clinical use in settings where vagus nerve stimulation therapy is administered, adhering to sterile procedures where applicable.
Frequently asked questions
What is the primary clinical purpose of the NCP Programming Wand and how does it integrate with the overall NCP System?
The NCP Programming Wand is designed specifically for programming and communicating with implanted devices like the Model 100 NCP Generator within the NeuroCybernetic Prosthesis (NCP) System. It functions as an autonomic nerve stimulator for vagus nerve stimulation, which is primarily intended for epilepsy management. The wand transmits signals to and from a computer via a DB9 cable, enabling clinicians to adjust and monitor therapy parameters in clinical settings where vagus nerve stimulation is administered.
How is the NCP Programming Wand powered and what are the key components of its supply package?
The NCP Programming Wand is powered by a single 9-volt battery. It is supplied as part of the complete NCP System, which includes the Model 100 NCP Generator, Model 300 Series Vagus Nerve Stimulation Lead, and other accessories. Since it is part of a system, it is not sold individually, and its use requires adherence to sterile procedures in clinical environments where vagus nerve stimulation therapy is provided.
Is the NCP Programming Wand intended for single-use or reusable applications, and what considerations should be taken during storage?
The NCP Programming Wand is not explicitly described as single-use or reusable in the provided data, but since it is part of an implantable system used in sterile clinical settings, it is likely designed for reuse with proper sterilization protocols. Storage should follow manufacturer guidelines to maintain functionality, though specific storage conditions (e.g., temperature, humidity) are not detailed in the data. Always refer to the manufacturer’s instructions for proper handling and maintenance.
What regulatory pathway was followed for the approval of the NCP Programming Wand, and what does this mean for clinicians or buyers?
The NCP Programming Wand was approved through the FDA’s Premarket Approval (PMA) process under PMA number P970003, which is part of the broader approval for the NeuroCybernetic Prosthesis (NCP) System. This means the device has undergone rigorous clinical evaluation to demonstrate safety and effectiveness for its intended use in vagus nerve stimulation therapy. Clinicians or buyers can rely on this approval when considering the device for epilepsy management in approved clinical settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Neurocybernetic Prosthesis (Ncp) Programming Wand, Model 201 NCP Programming Wand - Programmer, implantable, NEUROCYBERNETIC PROSTHESIS (NCP) SYSTEM PMA P970003S038 - FDA.report, VNS Therapy Product Manuals - LivaNova
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P970003 | Class III | Active |
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Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA PMA P970003 24 fields · synced Sep 18, 2026