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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 D-STAT FLOWABLE HEMOSTAT
Generic NameDevice, hemostasis, vascular
ApplicantVascular Solutions, Inc.
6464 SYCAMORE COURT NORTH
MINNEAPOLIS, MN 55369
PMA NumberP990037
Supplement NumberS025
Date Received06/14/2007
Decision Date07/17/2007
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE FOLLOWING WARNING TO THE LABELING: ?THE SAFETY AND EFFECTIVENESS OF D-STAT HAS NOT BEEN ESTABLISHED FOR USE TO CONTROL BLEEDING FOLLOWING ORGAN OR TISSUE BIOPSIES. USE OF D-STAT IN THIS SITUATION HAS BEEN REPORTED TO RESULT IN PAIN, SEIZURES, BILE RETENTION, TISSUE NECROSIS, VASCULAR OCCLUSION AND DEATH.?
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