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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.
 
DeviceTranscend 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 NumberS023
Date Received06/07/2021
Decision Date06/30/2021
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  
The firm identified a process optimization with its new HIP equipment (APG 3076-03 ). The intent of the process optimization (i.e., slight increase of the SR-T limits) in the HIP-sintering step is to ensure a better process capability as well as improved ceramic material and product properties.
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