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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 NumberS008
Date Received09/19/2006
Decision Date10/18/2006
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 WARNINGS AND PRECAUTIONS SECTION OF THE PACKAGE INSERT LABELING TO INCLUDE ADDITIONAL STATEMENTS THAT ADVISE THE SURGEON TO AVOID THE TAPER REGION AND SHELL FACE OF THE METAL ACETABULAR SHELL COMPONENT WHEN IMPACTING THE SHELL TO ADJUST THE POSITION OF THE COMPONENT.
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