Device Recall VNS Therapy AspireHC Pulse Generator

  • Modèle / numéro de série
    Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed to PA.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Société-mère du fabricant (2017)
  • Source
    USFDA