AFX EndoVascular AAA System

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The correction is not lot specific. It applies to AFX procedures conducted after June 2013

Cardiovascular Devices

3

Yes

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.

AFX Endovascular AAA System, Endoleak Type IIIA

The correction is not lot specific. It applies to AFX procedures conducted after July 2015

Cardiovascular Devices

3

Yes

Worldwide Distribution - US (nationwide) and Internationally to Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

AFX Endovascular AAA System, Endoleak Type IIIA || Common Name: AFX Bifurcated and Accessory Stent Grafts || Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment || The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).

Cardiovascular Devices

3

Yes

US, and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.

AFX Endovascular AAA System, Endoleak Type IIIB || Common Name: AFX Bifurcated and Accessory Stent Grafts || Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment

The correction is not lot specific. It applies to AFX procedures conducted after July 2015

Cardiovascular Devices

3

Yes

US and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.

AFX Endovascular AAA System, Endoleak Type IIIB; || The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).