Implantable Cardioverter Defibrillator

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.
  • Representante del fabricante
    Basic Trading sarl
  • Source
    RLMPH

74 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    St. Jude Medical: Ellipse™ Implantable Cardioverter Defibrillator
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    St. Jude Medical: Implantable Cardioverter Defibrillator
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    St. Jude Medical (Abbott): Implantable Cardioverter Defibrillators - See FSN.
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    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
  • Modelo / Serial
  • Descripción del producto
    Boston Scientific Ltd:Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families (see Appendix 2 for full details of models affected)
  • Manufacturer
69 más