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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원인
It has been identified that under exceptional circumstances an additional procedure may be required to remove the bifurcate body delivery system.
Model Catalog: OLB21 (Lot serial: ALL LOTS); Model Catalog: OLB23 (Lot serial: ALL LOTS); Model Catalog: OLB25 (Lot serial: ALL LOTS); Model Catalog: OLB28 (Lot serial: ALL LOTS); Model Catalog: OLB30 (Lot serial: ALL LOTS); Model Catalog: OLB32 (Lot serial: ALL LOTS); Model Catalog: OLB34 (Lot serial: ALL LOTS); Model Catalog: B34 (Lot serial: ALL LOTS); Model Catalog: B32 (Lot serial: ALL LOTS); Model Catalog: B30 (Lot serial: ALL LOTS); Model Catalog: B19 (Lot serial: ALL LOTS); Model Catalog: B25 (Lot serial: ALL LOTS); Model Catalog: B21 (Lot serial: ALL LOTS); Model Catalog: B28 (Lot serial: ALL LOTS)
제품 설명
ANACONDA STENT GRAFT SYSTEM - ONE-LOK BIFURCATE BODY WITH DELIVERY