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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.
 
DeviceDEPUY 3 BONE CEMENT
Generic NameBONE CEMENT
Regulation Number888.3027
ApplicantDEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW, IN 46581-0988
PMA NumberP960001
Supplement NumberS005
Date Received06/24/1998
Decision Date08/26/1999
Reclassified Date 10/14/1999
Product Code LOD 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site located at DePuy International, Blackpool, Lancashire FY4 4QQ, England.
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