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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 NameQUICK-CLOSE VASCULAR SUTURING SYSTEM
Classification Namedevice, hemostasis, vascular
ApplicantINTERVENTIONAL THERAPIES, LLC.
PMA NumberP080029
Supplement NumberS001
Date Received09/13/2010
Decision Date03/11/2011
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for ergonomic changes to the quick-close vascular suturing system.
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