Eon, Eon Mini and Brio

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SMPA

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Active implantable medical devices - biostimulators
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Eon, Eon Mini and Brio Implantable Pulse Generator (IPG) (Implantable Spinal Cord and Deep Brain Stimulators)Eon Implantable Pulse Generator (IPG)Product Code 64-3716 ARTG Number: 127126Eon Mini IPGProduct Code: 65-3788 ARTG Number: 154912Brio IPGProduct code 65-6788 ARTG Number: 164510
  • Manufacturer