ACCELERATOR APS SYSTEM

Fabricante

  • Dirección del fabricante
    MISSISSAUGA
  • 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
    HC

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Model Catalog: 7L02-01 (Lot serial: ALL); Model Catalog: 7L01-01 (Lot serial: ALL); Model Catalog: 7L06-01 (Lot serial: ALL); Model Catalog: 7L07-01 (Lot serial: ALL)
  • Descripción del producto
    ACCELERATOR APS SYSTEM
  • Manufacturer
  • Modelo / Serial
    LN 7L01-01.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Device distributed to a hospital in UT.
  • Descripción del producto
    ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; manufactured by Inpecco SpA, Segrate (MI), Italy.
  • Manufacturer
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide: including state of UT.
  • Descripción del producto
    Abbott ACCELERATOR APS System Input/Output Module (IOM); List Number: 7L01-01; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer