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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 NumberS010
Date Received10/12/2007
Decision Date11/14/2007
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
IMPLEMENTATION OF A MANUFACTURING CHANGE MADE BY THE CONTRACT SUPPLIER, CERAMTEC.
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