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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.
 
DeviceDIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 SYCAMORE COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Supplement NumberS019
Date Received05/16/2003
Decision Date06/13/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A SHELF-LIFE EXTENSION OF THE TRIS DILUENT COMPONENT, FOR THE DEVICES LISTED ABOVE, FROM THE APPROVED 24 MONTHS TO 36 MONTHS.
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