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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 AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 SYCAMORE COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Supplement NumberS012
Date Received01/17/2003
Decision Date01/30/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE TO THE DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE. SPECIFICALLY, 1) REMOVAL OF THE SILICONE GASKET FROM THE PRESSURE RELIEF VALVE DESIGN; 2) REMOVAL OF A LUER LOCK THREAD/ATTACHMENT WHICH WAS USED TO CONNECT THE CATHETER TO THE PRESSURE RELIEF VALVE AND REPLACE WITH AN ADHESIVE BOND; 3) REMOVAL OF THE CAP COVER AND THREADS FROM THE RELIEF VALVE, AND 4) SHORTENING OF THE LENGTH AND HEIGHT OF THE RELIEF VALVE.
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