Wingspan Stent System

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    DMA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 6 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Wingspan Stent System, Stryker Neurovascular
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Implant-endovascular-therapeutic
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Batch numbers 13215033 and 13192372, Catalog/product UPN number M003WE0300150
  • 의료기기 분류등급
  • 의료기기 등급
    HDE
  • 이식된 장치?
    Yes
  • 유통
    International Distribution Only -- China, Germany, Italy, the Philippines, Portugal and Turkey.
  • 제품 설명
    Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA || Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels with less than or equal to 50% stenosis that are accessible to the system.
  • Manufacturer
하나 더 1 건 더