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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.
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Vascular Solutions, Inc.
6464 sycamore court north
minneapolis, MN 55369
PMA NumberP990037
Supplement NumberS007
Date Received11/28/2001
Decision Date12/31/2001
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes in the instructions for use that stratifies adverse events into diagnostic and interventional patient populations.