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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 NameVASOSEAL
Classification Namedevice, hemostasis, vascular
Generic Namevascular hemostasis device
ApplicantST. JUDE MEDICAL, INC.
PMA NumberP920004
Supplement NumberS021
Date Received12/14/2007
Decision Date01/11/2008
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the sponge plug rinse system from a semi-automated to a fully automated system.
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