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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
Applicant
MEDTRONIC 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 Trials NCT01807585
Expedited Review Granted? No
Combination Product No
Recalls CDRH 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).
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 S010 S011 S012 S013 S014 S015 S016 
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