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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 NumberS021
Date Received12/23/2019
Decision Date02/04/2020
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  
Updates to the drying and rinsing stations prior to visual inspection of parts for cracks.
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