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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.
 
DeviceVASCULAR SOLUTIONS DUETT SEALING DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS030
Date Received04/09/2010
Decision Date05/07/2010
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS FROM AN IN-HOUSE MANUFACTURED STERILIZATION PROCESS CONTROL DEVICE (SPCD) TO A COMMERCIALLY PURCHASED PCD.
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