Devices

Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

  • Modelo / Serial
    Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
  • Descripción del producto
    SJM Confirm, Implantable Cardiac Monitor (ICM) Models: DM2100, DM2102 (IDE). || This product is a lead less non-therapeutic implantable cardiac monitor and is implanted to aid clinicians in diagnosing intermittent symptoms which may be due to arrhythmia
  • Manufacturer
    St Jude Medical CRMD
  • 1 Event

Fabricante

St Jude Medical CRMD
  • Dirección del fabricante
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA