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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 SEALING DEVICE
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 SYCAMORE COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Supplement NumberS013
Date Received01/23/2003
Decision Date02/21/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING ACHANGE IN THE MANUFACTURING PROCEDURES TO PROPOSE REDUCTION IN POUCH AND SEAL STRENGTH TOLERANCE, TOLERANCE CHANGE TO THE KNOB BASE AND HUB BASE, CHANGES TO THE SEALING AND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.ND PILOT BALLOONS, SLEEVE MARKING CHANGES AND REDUCTION IN THE BIOBURDEN MONITORING LIMITS FOR THE DUETT FAMILY OF SEALING DEVICES.
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