Device Recall VNS(R) Therapy Programmer

  • Model / Serial
    Part Number: 10-0011-0500 Serial number/UDI: 8LYB7F2/010542502575039911170920218LYB7F29910-0011-0500 D80C7F2/01054250257503991117092921D80C7F29910-0011-0500
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : CO and ND
  • Product Description
    VNS(R) Therapy Programmer, GMDN: 44077, Model 3000 v1.0.2.2 || Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • Manufacturer Parent Company (2017)
  • Source
    USFDA