Abbott Vascular Division of Abbott Australasia Pty Ltd

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Description

8 dispositivos en la base de datos

  • Modelo / Serial
    Absorb Bioresorbable Vascular Scaffold (BVS) SystemARTG Number: 214148
  • Clasificación del producto
  • Modelo / Serial
    NC Trek Rx Coronary Dilatation SystemMultiple Part and Lot NumbersARTG Number: 189474
  • Clasificación del producto
  • Modelo / Serial
    StarClose SE Vascular Closure System (VCS), International Green SheathPart Number: 14679-02Multiple Lot NumbersARTG Number: 240055
  • Modelo / Serial
    Absorb Bioresorbable Vascular Scaffold (BVS) SystemAll sizes affectedARTG Number: 214148
  • Modelo / Serial
    MitraClip System (Product Number # MSK02ST) containing the Clip Delivery System (Part number # CDS02ST) and the Steerable Guide Catheter (Part number # SGC01ST)(Used for reconstruction of the insufficient mitral valve through tissue approximation)Lot numbers: 50714U1 and higherARTG numbers:177709 and 189720
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Más información acerca de la data acá

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.
  • Representante del fabricante
    Medilife S.A.L
  • Source
    RLMPH