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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.
 
DeviceANGIOLINK VASCULAR CLOSURE SYSTEM
Generic NameDevice, hemostasis, vascular
ApplicantMedtronic Vascular
37A Cherry Hill Drive
Danvers, MA 01923
PMA NumberP040022
Date Received04/26/2004
Decision Date11/03/2004
Withdrawal Date 10/12/2010
Product Code MGB 
Docket Number 04M-0496
Notice Date 11/12/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S001 S003 
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