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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
Applicant
Vascular Solutions, Inc.
6464 sycamore court north
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 Product No
Approval Order Statement 
APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE MANUAL.
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