Medtronic Strata II

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
  • Description du dispositif
    md
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers:  D22311; D37565.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.
  • Description du dispositif
    Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. || Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.
  • Manufacturer
  • Modèle / numéro de série
    Medtronic Strata II/Strata NSC Valves (including Burr Hole and Lumbar Peritoneal [LP]) used in the management of hydrocephalusMultiple Catalogue NumbersAll Lot NumbersARTG Numbers: 111909, 129681, 134740, 145335, 145337, 165018, 169054, 169061
  • Manufacturer