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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 NameSTARCLOSE SE VASCULAR CLOSURE SYSTEM IFU
Classification Namedevice, hemostasis, vascular
Generic Namevascular closure system
ApplicantABBOTT VASCULAR INC.
PMA NumberP050007
Supplement NumberS028
Date Received02/22/2011
Decision Date03/24/2011
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add adjunctive compression language to the labeling and instructions for use.
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