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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.
 
Trade NameVASCULAR SOLUTIONS D-STAT FLOWABLE HEMOSTAT
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantVASCULAR SOLUTIONS, INC.
PMA NumberP990037
Supplement NumberS025
Date Received06/14/2007
Decision Date07/17/2007
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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