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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Supplement NumberS012
Date Received01/17/2003
Decision Date01/30/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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