HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT

Fabricante

  • Dirección del fabricante
    MIAMI LAKES
  • 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
    HC

4 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Model Catalog: 1104 (Lot serial: All lots prior to HW25838.)
  • Descripción del producto
    HEARTWARE VENTRICULAR ASSIST SYSTEM HVAD - IMPLANT KIT
  • Manufacturer
  • Modelo / Serial
    Model Catalog: 1104XX (Lot serial: CON000001 to CON210000.)
  • Descripción del producto
    HEARTWARE VENTRICULAR ASSIST SYSTEM
  • Manufacturer
  • Modelo / Serial
    Model Catalog: 1470CA (Lot serial: >10. Contact mfr)
  • Descripción del producto
    HEARTWARE VENTRICULAR ASSIST SYSTEM - HVAD IMPLANT KIT
  • Manufacturer
  • Modelo / Serial
    Model Catalog: ASY00281 (Lot serial: 480786 THROUGH 880816); Model Catalog: ASY00116 (Lot serial: 480786 THROUGH 880816)
  • Clasificación del producto
  • Descripción del producto
    DRIVELINE SPLICE REPAIR KIT
  • Manufacturer