Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    SATP

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    See FSN | All serial numbers of the affected devices | Merlin Programmer - Model 3330 Version 23.1.2
  • Product Classification
  • Product Description
    AIMD: Defibrillator, implantable
  • Manufacturer
  • Model / 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
  • Manufacturer