FDA-Device2017-01-25Class II
AFX Endovascular AAA System, Endoleak Type IIIA
Endologix
Hazard
Endologix initiated a correction by updating reports for the cumulative clinical data and information on the Powerlink System and the AFX Endovascular AAA System (AFX System).
Sold states
Worldwide Distribution - US Distribution and to the countries of : Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Affected count
40,967
Manufactured in
35 Hammond, Irvine, CA, United States
Products
AFX Endovascular AAA System, Endoleak Type IIIA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1035-2017Don't want to check this manually?
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