Device Recall VNS Therapy AspireHC Pulse Generator

  • Modelo / Serial
    Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Distributed to PA.
  • Descripción del producto
    Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. || Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA