ev3, Inc.

¿Qué es esto?

Description

  • Dirección del fabricante
    ev3, Inc., 651 Campus Drive, St. Paul MN 55112-3495
  • Source
    USFDA
  • 1 Event

Un dispositivo en la base de datos

  • Modelo / Serial
    Lot Number 132612
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide in United States.
  • Descripción del producto
    Prot¿g¿ Self-Expanding Nitinol Stent 6 mm x 40 mm, Model Number SER6-6-40-135

4 fabricantes con un nombre similar

Más información acerca de la data acá

  • Dirección del fabricante
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA
  • Dirección del fabricante
    ev3, Inc., 3033 Campus Drive, Minneapolis MN 55441
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA
  • Dirección del fabricante
    ev3, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • Source
    USFDA
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Representante del fabricante
    Allied Medical S.A.L.
  • Source
    RLMPH