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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
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, IN 46581-0988
PMA NumberP040023
Supplement NumberS007
Date Received05/04/2006
Decision Date05/26/2006
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR AN ADDITIONAL LABEL BEING ADDED TO THE DEVICE OUTER PACKAGE THAT STATES, "WARNING: ONLY COMPATIBLE WITH OPTION SERIES IMPLANTS".
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