Abbott Vascular Division of Abbott Australasia Pty Ltd

8 dispositifs dans la base de données

  • Modèle / numéro de série
    Absorb Bioresorbable Vascular Scaffold (BVS) SystemARTG Number: 214148
  • Classification du dispositif
  • Modèle / numéro de série
    NC Trek Rx Coronary Dilatation SystemMultiple Part and Lot NumbersARTG Number: 189474
  • Classification du dispositif
  • Modèle / numéro de série
    StarClose SE Vascular Closure System (VCS), International Green SheathPart Number: 14679-02Multiple Lot NumbersARTG Number: 240055
  • Modèle / numéro de série
    Absorb Bioresorbable Vascular Scaffold (BVS) SystemAll sizes affectedARTG Number: 214148
  • Modèle / numéro de série
    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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  • 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.
  • Représentant du fabricant
    Medilife S.A.L
  • Source