Abbott Medical Australia Pty Ltd

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Description

  • 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
    DHTGA
  • 2 Event

2 dispositivos en la base de datos

  • Modelo / Serial
    Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse ICD & CRT-D DevicesBattery performance update applies to devices manufactured prior to 23 May 2015Multiple ModelsMultiple ARTG Numbers
  • Modelo / Serial
    HeartMate 3 Left Ventricular Assist System Catalogue Number: 106524INT LVAS KIT, HM3 ARTG Number: 300895(Abbott Medical Australia - HeartMate 3 LVAS Implant Kit Model 106524INT - Implantable ventricular circulatory assist system)
  • Clasificación del producto