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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-ON-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 NumberS003
Date Received11/21/2005
Decision Date12/22/2005
Withdrawal Date 04/03/2014
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE LABELING THAT INCLUDE: 1) THE ADDITION OF AN INTRAOPERATIVE PRECAUTION ADVISING THE SURGEON OF THE NECESSITY FOR CORRECT POSITIONING OF THE INSERT COMPONENT PRIOR TO ASSEMBLING IT TO THE METAL OUTER SHELL AND EXAMINING THE CERAMIC LINER FOLLOWING FINAL ASSEMBLY, AND 2) UPDATING THE ADVERSE EVENT TABLE TO REFLECT THE HIGHER RATE OF INTRAOPERATIVE CHIPPING EXPERIENCED IN THE FIRST SIX MONTHS OF U.S. DISTRIBUTION.
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