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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 WOVEN DOUBLE VELOUR GRAFTS
Classification Nameprosthesis, vascular graft, of 6mm and greater diameter
Generic Namehemashield
Regulation Number870.3450
ApplicantMEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
PMA NumberP840029
Supplement NumberS005
Date Received04/19/1991
Decision Date05/11/1993
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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