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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 ON 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 NumberS002
Date Received11/10/2005
Decision Date12/12/2005
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes in quality controls to various components of this system. These changes include modification to several manufacturing process specifications (mps) for gamma vacuum foil (gvf) packaged products: 1) to add physical separation barriers to the sealing machine to prevent adjacent foil pouches from overlapping during the sealing operation, and 2) to require a second 100% inspection of the seal integrity of each package prior to shipment.
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