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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
ApplicantVascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS006
Date Received05/21/2001
Decision Date06/14/2001
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LABELING CHANGES IN THE INSTRUCTIONS FOR USE THAT ADD AND STRENGTHEN THE PRECAUTIONS AND INSTRUCTIONS.
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