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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 COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Supplement NumberS003
Date Received02/07/2001
Decision Date03/22/2001
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE INSTRUCTINOS FOR USE MANUAL TO INCLUDE THE OUTCOME DATA (REGISTRY RESULTS) REGARDING PATIENTS TREATED WITH PLATELET GP IIB/IIIA INHIBITORS.
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