Fortify ST

  • Modèle / numéro de série
    CD1235-40, CD1235-40Q, CD2235-40 and CD2235-40Q | All
  • Description du dispositif
    AIMD: Implant, cardiac pacemaker
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP

4 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: St Jude Medical Fortify ST Implantable cardioverter defibrillator
  • Manufacturer
  • Modèle / numéro de série
    Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices(Implantable cardiac defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices)Manufactured between January 2010 and May 2015Fortify VRFortify ST VRFortify Assura VRFortify DRFortify ST DRFortify Assura DRUnifyUnify QuadraUnify Quadra MPUnify AssuraQuadra AssuraQuadra Assura MPMultiple ModelsMultiple ARTG Numbers
  • Manufacturer