Pipeline Embolization Device (PED)

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    SATP

4 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    all codes
  • Description du dispositif
    Pipeline Embolization Device (PED)
  • Manufacturer
  • Modèle / numéro de série
  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Non-active implants - special implants
  • Manufacturer
  • Modèle / numéro de série
    PED Model/ Lot  FA7735014 / 9879718  FA7742512 / 9864827 FA7150035 / 9855921 FA7735016 / 9856429  FA7742518 / 9856431 FA7730010 / 9869991  FA7737514 / 9855933  FA7742518 / 9860762 FA7732514 / 9873854  FA7737516 / 9858010  FA7745014 / 9874111 FA7735014 / 9855265  FA7740016 / 9859214  FA7745016 / 9879736 FA7735014 / 9875267  FA7740016 / 9879180  FA7747514 / 9868888
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Germany, France, UK, Turkey, Argentina, Canada, Colombia, Mexico, , Austria, Belgium, Denmark, Hungary, Italy, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Switzerland, and UAE.
  • Description du dispositif
    Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
  • Manufacturer