3f Enable Aortic Bioprosthesis

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.
  • Représentant du fabricant
    Gulf Medical Co., (012) 6512828
  • Source
    SFDA

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    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: )
  • Description du dispositif
    3f enable aortic bioprosthesis
  • Manufacturer
  • Modèle / numéro de série
    3f Enable Aortic Bioprosthesis - Model 6000Supplied in Australia under either Special Access Scheme, as an Authorised Prescriber or under a Clinical Trial
  • Manufacturer