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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 NumberS008
Date Received02/04/2011
Decision Date02/25/2011
Withdrawal Date04/29/2026
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF TWO ¿LIKE TO LIKE¿ MACHINES USED FOR THE FOLLOWING MANUFACTURING PROCESSES OF THE CERAMIC BALL HEADS: 1) GRINDING THE INNER BORE AND CHAMFER; AND 2) POLISHING THE OUTER BALL HEAD CONTOUR.
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