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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
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
Vascular Solutions, Inc.
6464 sycamore court north
minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS026
Date Received07/11/2008
Decision Date08/07/2008
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE QUALITY CONTROL DEVICE USED TO MONITOR THE STERILIZATION PROCESS, AND A CHANGE IN THE MATERIALS USED IN ONE ACCESSORY COMPONENT (SMALL BORE APPLICATOR TIP).
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