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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.
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
PMA NumberP040022
Date Received04/26/2004
Decision Date11/03/2004
Withdrawal Date 10/12/2010
Product Code
MGB[ Registered Establishments with MGB ]
Docket Number 04M-0496
Notice Date 11/12/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the evs vascular closure system. The device is indicated for percutaneous femoral artery approximation. The evs vascular closure system is also indicated to reduce time to hemostasis at femoral puncture sites and to reduce time to ambulation for patients undergoing diagnostic and interventional catheterization procedures using 6-8 french procedural sheaths.
Approval Order Approval Order
Supplements: S001 S002 S003