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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
Generic NameStent, superficial femoral artery, drug-eluting
ApplicantCook Ireland, Ltd.
O'Halloran Road
National Technology Park
Limerick 
PMA NumberP100022
Date Received06/04/2010
Decision Date11/14/2012
Product Code NIU 
Docket Number 12M-1146
Notice Date 11/30/2012
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S012 S020 S009 S014 S015 S016 S002 S004 S003 S013 
S011 S006 S007 S010 S008 S017 S018 S022 S023 S024 S021 S025 
S028 S029 S026 S033 S034 S035 S038 S039 S040 S037 S042 S027 
S032 S030 S031 S036 S041 
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