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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.
 
DeviceCeramic 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 NumberS026
Date Received08/10/2023
Decision Date09/06/2023
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 a grinding machine for grinding the outer surface of ceramic inserts in the TRANSCEND® Hip Articulation System.
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