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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When an implanted device approaches the recommended replacement time (rrt) the residual longevity estimate provided by the programmer at follow-up may be overestimated which could result in reaching rrt between two follow-up visits. until a new programmer software version is approved livanova is providing a number of patient management recommendations.