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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantCERAMTEC GMBH
CERAMTEC-PLATZ 1-9
73207
PLOCHINGEN 73207
PMA NumberP010001
Supplement NumberS006
Date Received04/21/2010
Decision Date09/15/2010
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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