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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 NumberS020
Date Received07/11/2019
Decision Date08/09/2019
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Addition of polishing machine used for polishing the intake and polishing the inner sphere of the ceramic inserts of the Transcend Hip Articulation System.
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