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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.
 
DeviceCERAMTEC CERAMIC TRANSCEND HIP ARTICULATION 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
CERAMTEC GMBH
ceramtec-platz 1-9
73207
plochingen 73207
PMA NumberP010001
Supplement NumberS004
Date Received07/18/2007
Decision Date08/17/2007
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of new software to allow polished inserts to be reworked, following inspection, in one of two inner sphere polishing stations.
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