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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 SOLUTIONS DUETT SEALING DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 SYCAMORE COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Supplement NumberS010
Date Received02/27/2002
Decision Date04/30/2002
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 CHANGING THE SUPPLIER FROM COOK PHARMACEUTICALS TO CHESAPEAKE BIOLOGICAL LABORATORIES. THIS CHANGE WILL ALSO AFFECT THE APPROVED DILUENT. SPECIFICALLY, THE CURRENT APPROVED BUFFERING AGENT COMPONENT, 0.1% TROLAMINE NF (TEA) WILL BE CHANGED TO 0.1% TROMETHAMINE USP (TRIS).
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