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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 NameHEMASHIELD ETS(TM) FLANGED GRAFT
Classification Nameprosthesis, vascular graft, of 6mm and greater diameter
Generic Namehemashield
Regulation Number870.3450
ApplicantMEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
PMA NumberP840029
Supplement NumberS004
Date Received10/24/1990
Decision Date05/17/1993
Product Code
DSY[ Registered Establishments with DSY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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