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.
  • Source
    NIDFSINVIMA

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Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    Medical electronics / Electromedical devices - electrotherapy
  • Manufacturer
  • Modelo / Serial
    VALITUDE™ CRT-P U125, U128 RESONATE™ CRT-D G424, G425, G426, G428, G437, G447, G448, G524, G525, G526, G528, G537, G547, G548 MOMENTUM™ CRT-D G124, G125, G126, G128, G138 AUTOGEN™ CRT-D G172, G173, G175, G177, G179 INOGEN™ CRT-D G140, G141, G146, G148 VISIONIST™ CRT-P U225, U226, U228 VIGILANT™ CRT-D G224, G225 , G228, G237, G247, G248 CHARISMA™ CRT-D G324, G325, G328, G337, G347, G348 DYNAGEN™ CRT-D G150, G151, G156, G158 ORIGEN™ CRT-D G050, G051, G056, G058
  • Manufacturer
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