U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
원인
Mispackaging-protege gps ser6-9-60-125 devices were incorrectly packaged as ser6-7-80-135. diameter is larger than expected.
조치
An ev3 field representative will notify affected consignees in person beginning 2/27/2006. Product retrieval or use of the device will be documented using on a ''Field Action Form''. Account credit or product from an unaffected lot number will be provided.
ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of nickel titanium alloy (Nitinol) and comes pre-mounted on an over-the-wire delivery system. The stent is cut from a nitinol tube into an open lattice design and is designed with tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts.