Implantable Pulse Generators (IPGs)

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
    MHSIDCCCDMIS

7 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
  • Implanted device?
    Yes
  • Product Description
    Active implant
  • Manufacturer
  • Model / Serial
  • Product Description
    St. Jude Medical: Implantable Pulse Generators (IPGs)
  • Manufacturer
  • Model / Serial
  • Product Description
    Implantable Pulse Generators (IPGs) – Neurostimulators. Eon Mini™ (Model 65-3788) and Brio™ (Model 65-6788).Manufactured by St Jude Medical.
  • Manufacturer
  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including Washington D.C., Guam, Puerto Rico, and Virgin Islands; Albania, Algeria, Argentina, Armenia, Aruba, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latin America, Latvia, Lebanon, Luxembourg, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, Norway, Oman, Pakistan, Palestinian Territory Occupied, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Senegal, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Vatican City State (Holy See), and Venezuela.
  • Product Description
    Medtronic KAPPA 600/700/900 Series Implantable Pulse Generator (IPGs), Dual Chamber atrial sensing, ventricular sensing and pacing Pacemaker, models KVDD701 and KVDD901.
  • Manufacturer
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