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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 NumberS016
Date Received12/11/2009
Decision Date09/02/2010
Withdrawal Date 04/03/2014
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO AN AUTOMATED CLEANING PROCESS AND COMBINATION OF THAT CLEANING PROCESS WITH THE FINAL POLISH PROCESS ON THE FIRM¿S ROUTERS.
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