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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceDUETT PRO SEALING DEVICE MODEL 1010
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
Vascular Solutions, Inc.
6464 sycamore court north
minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS022
Date Received06/15/2004
Decision Date07/09/2004
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at steris corp. , isomedix services, minneapolis, minnesota.
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