QuickSite

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP

11 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Active implantable medical devices - cardiac pacemakers
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: St. Jude Medical QuickSite® and QuickFlex® Left Ventricular CRT Leads [Models 1056T, 1058T, 1156T and 1158T]
  • Manufacturer
  • Model / Serial
    All lots
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- Algeria, Argentina, Australia, Austria, Bahrain, Balkan, Baltic, Belarus, Belgium, Bolivia, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Montenegro, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Oman, Paraguay, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Senegal, Serbia, Serbia Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, US, Venezuela, and Yemen.
  • Product Description
    Cardiac Resynchronization Therapy (CRT) Leads. || Trade Name: QuickSite, QuickSite XL || Model Numbers: QuickSite and QuickSite XL: Models 1056T, model 1058T || Intended use: Left Ventricular Cardiac Resynchronization Therapy Lead
  • Manufacturer
6 more