Advantage System

  • Modèle / numéro de série
    M0068502000; M006850200051, M0068502111 | ML00000035, ML00000036; ML00000038
  • Description du dispositif
    MD: Surgical mesh kit; Laser beam delivery unit, fibreoptic; Ligation clip, metallic
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SATP

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  • Modèle / numéro de série
  • Description du dispositif
    They are indicated for the treatment of stress urinary incontinence caused by hypermobility or sphincterintrinsic deficiency.
  • Manufacturer