VNS Therapy System

FDA premarket approval P970003 · Stimulator, autonomic nerve, implanted for epilepsy

PMA numberP970003

Approval

Applicant
LivaNova USA, Inc.
Received
January 27, 1997
Decision date
July 16, 1997 (APPR)
Supplements
237, latest August 12, 2026
Product code
LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy

Official FDA PMA record

Approval order statement

Approval for the NeuroCybernetic Prosthesis (NCP(R)) System which includes the Model 100 NCP Generator, the Model 300 Series NCP Vagus Nerve Stimulation Lead, the Model 400 Tunneling Tool, and NCP System Accessories.