endurant / endurant ii

Fabricante

  • 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
    MSHM

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
  • Descripción del producto
    Class III
  • Manufacturer
  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Argentina Armenia Australia Austria Belgium Brazil Bulgaria Canada China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Finland France French Polynesia Germany Greece Hong Kong Hungary Iceland India Indonesia Iran Ireland Israel Italy Japan Jordan Kazakhstan Korea Kuwait Latvia Lebanon Lithuania Luxembourg Malaysia Mexico Montenegro Netherlands New Zealand Norway Oman Panama Paraguay Peru Philippines Poland Portugal Reunion Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sri Lanka Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom Uruguay Venezuela Viet Nam
  • Descripción del producto
    Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems || Model Numbers: || ETBF2516C145E || ETBF2516C166E || ETBF2316C145E || ETBF2313C145E || ETBF2513C166E || ETBF2313C166E || ETBF2316C166E || ETBF2313C124E || ETBF2513C145E || ETBF2516C124E || ETBF2316C124E || ETBF2513C124E. || Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature.
  • Manufacturer
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Non-active implants - special implants
  • Manufacturer
  • Modelo / Serial
    Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems(indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms)Multiple Product and Serial NumbersARTG Numbers: 158456, 197539
  • Clasificación del producto
  • Manufacturer