THORATEC CORPORATION

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Description

13 devices in the database

  • Model / Serial
    Model Catalog: (Lot serial: )
  • Product Description
    THORATEC TLC-II PORTABLE VAD DRIVER
  • Model / Serial
    Model Catalog: 107801 (Lot serial: ALL); Model Catalog: 106015 (Lot serial: ALL); Model Catalog: 106762 (Lot serial: ALL)
  • Product Classification
  • Product Description
    HeartMate II LVAS Implant Kit
  • Model / Serial
    Model Catalog: 103695 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 103696 (Lot serial: >100 NUMBERS CONTACT MFG)
  • Product Description
    THORATEC HEARTMATE II LEFT VENTRICULAR
  • Model / Serial
    Model Catalog: 104911 (Lot serial: ALL LOTS); Model Catalog: 104692 (Lot serial: ALL LOTS); Model Catalog: 103393 (Lot serial: ALL LOTS)
  • Product Description
    HM II Implant Kit Sealed
  • Model / Serial
    Model Catalog: 10012-2555-001 (Lot serial: >10 serial #'s contact manufr)
  • Product Classification
  • Product Description
    Thoratec IVAD Pump
8 more

29 manufacturers with a similar name

Learn more about the data here

  • 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
    NIDFSINVIMA
  • Manufacturer Address
    Thoratec Corporation, 6035 Stoneridge Dr, Pleasanton CA 94588-3270
  • 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
  • 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
    ALIMSA
  • 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
    AEMPSVFOI
24 more