Promote Quadra

  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide distribution
  • Product Description
    Promote Quadra, Sterile EO, Model # / Part #: || CD3221-36/100025054, 60019195; || CD3223-36P/100013763; || CD3239-40/100029115, 100029254, 100037181; || CD3239-40Q/100029116, 100029244, 100037115
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    St Jude Medical Inc., 15900 Valley View Ct, Sylmar CA 91342-3577
  • 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
    USFDA

5 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model Number: viz FSN
  • Product Description
    Active implantable medical devices
  • Manufacturer
  • Model / Serial
  • Product Description
    1. Merlin PCS 3650 Software Upgrade Kit , 2. Merlin@home Transmitter Software, 3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™), St. Jude Medical, Cardiac Rhythm Management Division
  • Manufacturer
  • Model / Serial
    Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse ICD & CRT-D DevicesBattery performance update applies to devices manufactured prior to 23 May 2015Multiple ModelsMultiple ARTG Numbers
  • Manufacturer