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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceCLOSER VASCULAR SEALING SYSTEM
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
REX 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[ Registered Establishments with MGB ]
Docket Number 16M-0805
Notice Date 03/03/2016
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 
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