3f Enable Aortic Bioprosthesis

Fabricante

  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.
  • Representante del fabricante
    Gulf Medical Co., (012) 6512828
  • Source
    SFDA

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Model Catalog: 6550 (Lot serial: ); Model Catalog: 6000-27 (Lot serial: ); Model Catalog: 6000-25 (Lot serial: ); Model Catalog: 5000 (Lot serial: ); Model Catalog: 6000-21 (Lot serial: ); Model Catalog: 6000-19 (Lot serial: ); Model Catalog: 6000-23 (Lot serial: )
  • Descripción del producto
    3f enable aortic bioprosthesis
  • Manufacturer
  • Modelo / Serial
    3f Enable Aortic Bioprosthesis - Model 6000Supplied in Australia under either Special Access Scheme, as an Authorised Prescriber or under a Clinical Trial
  • Manufacturer