HeartMate II LVAS System Controller

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
    DMA

7 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Active implantable medical devices
  • Manufacturer
  • Model / Serial
    Catalog Number: 106015, 106016, 106762, 106017, 107801 Model Number: 105109 (Pocket Controller)
  • Product Description
    Active implantable medical devices
  • Manufacturer
  • Model / Serial
  • Product Description
    Thoratec Corporation: HeartMate II LVAS system controller
  • Manufacturer
  • Model / Serial
    106015, 106016, 106762, 106017, 107801 | 7.13, 7.16, 7.18, 7.19
  • Product Classification
  • Product Description
    AIMD: Artificial heart external power supply unit
  • Manufacturer
  • Model / Serial
    105109, catalogue: 106016 and 106017 | all | 7.29
  • Product Description
    AIMD: Implantable ventricular circulatory assist system control unit
  • Manufacturer
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