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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 DRIVE
WAYNE, NJ 07470
PMA NumberP840029
Supplement NumberS009
Date Received01/21/1992
Decision Date05/11/1993
Reclassified Date 05/10/2001
Product Code DSY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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