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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
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
Vascular Solutions, Inc.
6464 sycamore court north
minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS019
Date Received05/16/2003
Decision Date06/13/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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