BIOTRONIK, Inc.

  • Dirección del fabricante
    BIOTRONIK, Inc., 6024 Jean Rd, Lake Oswego OR 97035-5571
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA
  • 1 Event

Un dispositivo en la base de datos

  • Modelo / Serial
    Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). || Allows physicians to program devices to pace exclusively in the left ventricle.