Abbott Vascular, Inc.

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Description

Un dispositivo en la base de datos

  • Modelo / Serial
    Lot Numbers starting from 43034-6H to 47139-6H
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution, including USA, Puerto Rico, and 410 other countries. There were no shipments to Canada and Mexico.
  • Descripción del producto
    StarClose Vascular Closure System (Clip Applier & Exchange System), || Catalog Number: 14677; || Product is manufactured by: || Abbott Vascular Inc., || 400 Saginaw Drive, || Redwood City, CA 94063

2 fabricantes con un nombre similar

Más información acerca de la data acá

  • 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
    AEMPSVFOI
  • Dirección del fabricante
    Abbott Vascular, Inc., 26531 Ynez Rd, Temecula CA 92591-4630
  • 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
    USFDA