Heartmate III

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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

3 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    Thoratec HeartMate III LVAS Implant kit ,Thoratec HeartMate III Sealed Outflow Graft with Bend Relief, Thoratec Corporation
  • Manufacturer
  • Model / Serial
  • Product Description
    Thoratec HeartMate III™ LVAS Implant Kit, Thoratec Corporation
  • Manufacturer
  • Model / Serial
    106524INT - LVAS KIT, HM 3105581I Packaged assembly Outflow, HM3(INT)
  • Product Description
    AIMD: Implantable ventricular circulatory assist system
  • Manufacturer