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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDURALOC OPTION CERAMIC HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nametotal hip system,ceramic articulation
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP040023
Supplement NumberS020
Date Received03/27/2012
Decision Date04/26/2012
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the sterile barrier package sealing process used for the ceramic femoral heads and acetabular liners.
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