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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMICROVEL(R) WITH HEMASHIELD
Generic NamePROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Regulation Number870.3450
ApplicantMAQUET CARDIOVASCULAR, LLC
45 BARBOUR POND DRIVE
WAYNE, NJ 07470
PMA NumberP840029
Date Received06/28/1984
Decision Date04/26/1989
Reclassified Date 05/10/2001
Product Code DSY 
Docket Number 89M-0170
Notice Date 06/06/1989
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Supplements:  S002 S004 S005 S006 S007 S008 S009 S010 S011 S014 S015 
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