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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVASCULAR SOLUTION DUETT SEALING DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 SYCAMORE COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Supplement NumberS008
Date Received12/11/2001
Decision Date05/29/2002
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE DELIVERY CANNULAE AND THE PROCOAGULANT AND CHANGING THE BUFFERING AGENT IN THE DILUTENT TO TROMETHAMINE USP (TRIS). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DUETT FLOWABLE HEMOSTAT DEVICE AND IS INDICATED FOR USE AS ADJUNCT TREATMENT IN OBTAINING HEMOSTASIS IN SEALING RESIDUAL OOZING OF TISSUE TRACTS OF FEMORAL ACCESS SITES THAT HAVE BEEN PREVIOUSLY CLOSED BY SUTURE MEDIATED/COLLAGEN-BASED HEMOSTATIC DEVICES.
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