Device Recall SJM Confirm, Implantable Cardiac Monitor (ICM)

  • Modèle / numéro de série
    Confirm DM2100, DM2102 (IDE). Software Version 10.1.1.2
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: (USA) Nationwide including the States of CA, WA, FL, WV, NY, MD and LA, and the country of Germany
  • Description du dispositif
    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
  • 1 Event

Fabricant

  • Adresse du fabricant
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA