VENTRICULAR ASSIST DEVICE (VAD)

Fabricante

  • Dirección del fabricante
    PLEASANTON
  • 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

6 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Dual Drive Console | 301 to 636
  • Descripción del producto
    AIMD: Circulatory assist system, ventricular
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    AIMD: Circulatory assist system, ventricular
  • Manufacturer
  • Modelo / Serial
    Model Catalog: 20010-0000-081 (Lot serial: Serviced/manuf'd since Aug2005)
  • Descripción del producto
    Thoratec TLC-II Portable VAD Driver
  • Manufacturer
  • Modelo / Serial
    Model Catalog: 10025-2600-005 (Lot serial: Serial numbers 301 through 636)
  • Descripción del producto
    Thoratec VAD Dual Drive Console
  • Manufacturer
  • Modelo / Serial
    Model Catalog: 20010-0000-081 (Lot serial: Serial #'s up to #631R); Model Catalog: 20010-2805-000 (Lot serial: Serial #'s up to #631R)
  • Descripción del producto
    TLC-II Portable VAD Driver
  • Manufacturer
Uno más