FDA Executive Summary
Prepared for the
October 13, 2011 meeting of the
Circulatory System Devices Advisory Panel
Zilver® PTX® Drug-Eluting Peripheral Stent System
This is the FDA Executive Summary for a first-of-a-kind drug-eluting peripheral stent, the Cook Zilver PTX Drug-Eluting Stent, indicated for use in the femoropopliteal arteries. This device has been reviewed by the Division of Cardiovascular Devices within the Center for Devices and Radiological Health of the Food and Drug Administration under Premarket Approval (PMA) application P100022, which is the subject of this Advisory Panel meeting.