Implantable cardioverter defibrillators (ICDs)

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
    MHRA

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  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Guidant implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) Device Family Model Numbers CONTAK RENEWAL© 4  H190, H195  CONTAK RENEWAL© 4 HE  H197, H199  CONTAK RENEWAL© 4 AVT  M170, M175  CONTAK RENEWAL© 4 AVT HE  M177, M179  RENEWAL© RF  H230, H235  RENEWAL© RF HE  H239
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    St. Jude Medical: All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ implantable cardioverter defibrillators (ICDs) and Assurity™ and Allure™ pacemakers when used with Merlin@home™ RF Remote Monitoring Transmitter Model EX1150.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.Manufactured by St Jude Medical.
  • Manufacturer
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