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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHEMASHIELD WOVEN DOUBLE VELOUR GRAFTS
Generic NamePROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
Regulation Number870.3450
ApplicantMaquet Cardiovascular, LLC
45 Barbour Pond Dr.
Wayne, NJ 07470
PMA NumberP840029
Supplement NumberS010
Date Received02/04/1992
Decision Date05/11/1993
Reclassified Date05/10/2001
Product Code DSY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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