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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.
 
DeviceZILVER PTX DRUG-ELUTING PERIPHERAL STENT
Classification Namestent, superficial femoral artery, drug-eluting
Generic Namestent, superficial femoral artery, drug-eluting
Applicant
COOK MEDICAL INCORPORATED
750 daniels way
p.o. box 489
bloomington, IN 47402-0489
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
Recalls CDRH Recalls
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S020 
S021 S023 S024 
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