Device Recall VNS Therapy AspireHC Pulse Generator

  • 모델명 / 제조번호(시리얼번호)
    Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Distributed to PA.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Cyberonics, Inc, 100 Cyberonics Blvd, Houston TX 77058-2069
  • 제조사 모회사 (2017)
  • Source
    USFDA