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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.
 
DeviceVASCULAR SOLUTIONS DUETT SEALING DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 SYCAMORE COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Date Received06/30/1999
Decision Date06/22/2000
Product Code MGB 
Docket Number 00M-1390
Notice Date 07/12/2000
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VASCULAR SOLUTIONS DUETT(TM) SEALING DEVICE. THIS DEVICE IS INDICATED FOR SEALING FEMORAL ARTERIAL PUNCTURE SITES AND REDUCING TIME TO HEMOSTASIS AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR PROCEDURES USING A 5F-9F INTRODUCER SHEATH WITH AN OVERALL LENGTH NOT EXCEEDING 15.2 CM.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S015 S018 S019 S020 S021 S022 S023 S024 S025 S026 
S028 S029 S030 S031 S032 S034 S035 S036 
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