HeartMate 3 Left Ventricular Assist System

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    DHTGA

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  • 모델명 / 제조번호(시리얼번호)
    HeartMate 3 Left Ventricular Assist System (LVAS)Catalogue Number: 106524INT – LVAS KIT, HM 3Serial Number: MLP-002965Supplied through the Special Access Scheme
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    HeartMate 3 Coring Extraction Tool || reference 10005872
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog # 106524INT – LVAS KIT, HM 3 105581INT – Packaged assembly Outflow, HM3(INT)
  • 제품 설명
    Mechanical circulatory support device
  • Manufacturer
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