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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.
 
DeviceSMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantCordis US Corporation
14201 NW 60th Avenue
Miami Lakes, FL 33014
PMA NumberP120002
Date Received02/03/2012
Decision Date11/07/2012
Product Code NIP 
Docket Number 12M-1183
Notice Date 12/05/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT00739102
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE S.M.A.R.T. CONTROL AND S.M.A.R.T. VASCULAR STENT SYSTEMS. THIS DEVICE IS INDICATED FOR USE TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF PATIENTS WITH DE NOVO OR RESTENOTIC NATIVE LESION(S) OF THE SUPERFICIAL FEMORAL ARTERY AND/OR PROXIMAL POPLITEAL ARTERY WITH TOTAL LENGTH UP TO 150 MM AND WITH A REFERENCE VESSEL DIAMETER RANGING FROM 4 MM TO 7 MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 
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