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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.
 
DeviceCLOSER VASCULAR SEALING SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantREX MEDICAL, L.P.
555 E. NORTH LANE SUITE 5035
CONSHOHOCKEN, PA 19428
PMA NumberP150022
Date Received06/25/2015
Decision Date02/12/2016
Product Code MGB 
Docket Number 16M-0805
Notice Date 03/03/2016
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Closer Vascular Sealing System (VSS). This device is indicated for the percutaneous closure of femoral artery access sites while reducing times to hemostasis and ambulation as compared to Performance Goals in patients who have undergone diagnostic or interventional endovascular procedures utilizing 5, 6 and 7 Fr procedural sheaths.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S005 S004 S007 
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