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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.
 
DeviceDURALOC OPTION CERAMIC HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP040023
Supplement NumberS010
Date Received10/12/2007
Decision Date11/14/2007
Withdrawal Date 04/03/2014
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF A MANUFACTURING CHANGE MADE BY THE CONTRACT SUPPLIER, CERAMTEC.
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