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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.
 
DeviceVENASEAL CLOSURE SYSTEM
Generic NameAgent, occluding, vascular, permanent
ApplicantMEDTRONIC VASCULAR INC
3033 Campus Drive
Plymouth, MN 55441
PMA NumberP140018
Date Received08/25/2014
Decision Date02/20/2015
Product Code PJQ 
Docket Number 15M-0690
Notice Date 02/20/2015
Advisory Committee Cardiovascular
Clinical TrialsNCT01807585
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VENASEAL CLOSURE SYSTEM. THIS DEVICE IS INDICATED FOR THE PERMANENT CLOSURE OF LOWER EXTREMITY SUPERFICIAL TRUNCAL VEINS, SUCH AS THE GREAT SAPHENOUS VEIN (GSV), THROUGH ENDOVASCULAR EMBOLIZATION WITH COAPTATION. VENASEAL IS INTENDED FOR USE IN ADULTS WITH CLINICALLY SYMPTOMATIC VENOUS REFLUX AS DIAGNOSED BY DUPLEX ULTRASOUND (DUS).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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 S028 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 
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