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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.
 
DeviceMISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantTERUMO MEDICAL CORPORATION
950 ELKTON BLVD
ELKTON, MD 21921
PMA NumberP140002
Date Received03/06/2014
Decision Date05/22/2015
Product Code NIP 
Docket Number 15M-1958
Notice Date 06/05/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT01118117
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN SYMPTOMATIC PATIENTS WITH DE NOVO OR RESTENOTIC NATIVE LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4MM TO 7MM AND LESION LENGTH UP TO 150MM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001  S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 
S013 S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 
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