Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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A new ifu has been approved with updated information. the updates to the ifu are of key importance when using the device to treat blunt thoracic aortic injury (btai) which is now covered under the newly approved indication for isolated lesions of the descending thoracic aorta. this safety communication is for informational purposes only and no devices need to be returned.