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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Classification Namestent, superficial femoral artery, drug-eluting
ApplicantCOOK MEDICAL INCORPORATED
PMA NumberP100022
Date Received06/04/2010
Decision Date11/14/2012
Product Code
NIU[ Registered Establishments with NIU ]
Docket Number 12M-1146
Notice Date 11/30/2012
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the zilver ptx drug-eluting peripheral stent. This device is indicated for improving luminal diameter for the treatment of de novo or restenotic symptomatic lesions in native vascular disease of the above-the-knee femoropopliteal arteries having reference vessel diameters from 4 mm to 9 mm and total lesion lengths up to 140 mm per limb and 280 mm per patient.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S004 
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