Specify 5-6-5 Surgical Lead and Specify 2x8 Surgical Lead

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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.
  • Manufacturers representative
    Medtronic Saudi Arabia
  • Source
    SFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Active implantable medical devices - biostimulators
  • Manufacturer
  • Model / Serial
  • Product Description
    Specify 5-6-5 Surgical Lead and Specify 2x8 Surgical Lead, Medtronic Inc.
  • Manufacturer
  • Model / Serial
  • Product Description
    Medtronic: Specify 5-6-5 surgical lead and Specify 2x8 surgical lead
  • Manufacturer