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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.
 
DeviceDUETT PRO SEALING DEVICE, DIAGNOSTIC DUETT PRO SEALING DEVICE AND D-STAT FLOWABLE HEMOSTAT
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 Sycamore Ct. N.
Minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS018
Date Received04/30/2003
Decision Date05/27/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT VASCULAR SOLUTIONS, INC., MINNEAPOLIS, MINNESOTA.
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