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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMICROVEL(R) WITH HEMASHIELD
Classification Nameprosthesis, vascular graft, of 6mm and greater diameter
Generic Namehemashield
Regulation Number870.3450
ApplicantMEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
PMA NumberP840029
Date Received06/28/1984
Decision Date04/26/1989
Reclassified Date 05/10/2001
Product Code
DSY[ Registered Establishments with DSY ]
Docket Number 89M-0170
Notice Date 06/06/1989
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S002 S004 S005 S006 S007 S008 S009 S010 S011 
S014 S015 
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