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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.
 
DeviceDUETT PRO SEALING DEVICE, MODEL 1010
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS028
Date Received10/21/2008
Decision Date12/17/2008
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO EXTENT THE SHELF LIFE OF THE SODIUM PHOSPHATE PROCOAGULANT DILUENT, USED ONLY IN THE DUET PRO SEALING DEVICE, MODEL 1010, FROM 2 YEARS TO 5 YEARS.
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