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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 NumberS007
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 replacement of two grinding machines and addition of one piece of proof testing equipment at the plochingen, germany facility and addition of a grinding machine and piece of proof testing equipment at the marktredwitz, germany facility.
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