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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 NameCERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nametotal hip system, ceramic articulation
ApplicantCERAMTEC AG
PMA NumberP010001
Supplement NumberS006
Date Received04/21/2010
Decision Date09/15/2010
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a second identical line of grinding, polishing, and cleaning processes at the plochingen, germany facility.
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