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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.
 
DeviceSUPERA PERIPHERAL STENT SYSTEM
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantABBOTT VASCULAR (IDEF TECHNOLOGIES INC)
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP120020
Date Received11/16/2012
Decision Date03/28/2014
Product Code NIP 
Docket Number 14M-0434
Notice Date 04/21/2014
Advisory Committee Cardiovascular
Clinical TrialsNCT00933270
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE SUPERA® PERIPHERAL STENT SYSTEM. THIS DEVICE IS INDICATED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF PATIENTS WITH SYMPTOMATIC DE NOVO OR RESTENOTIC NATIVE LESIONS OR OCCLUSIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERY, WITH REFERENCE VESSEL DIAMETERS OF 4.0 TO 6.5 MM, AND LESION LENGTHS UP TO 140 MM.
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 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 
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