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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 MODEL 1000 SEALING DEVICE
ApplicantVascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS002
Date Received01/22/2001
Decision Date03/14/2001
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE MANUAL.
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