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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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 S022 S023 S024 S025 
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