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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.
 
DeviceOSTEONICS ABC/TRIDENT SYSTEMS
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantHowmedica Osteonics Corp.
325 Corporate Dr.
Mahwah, NJ 07430
PMA NumberP000013
Supplement NumberS004
Date Received04/15/2004
Decision Date08/16/2004
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE TRIDENT "T" SHELL FOR USE WITH THE TRIDENT ALUMINA INSERT. THE TRIDENT "T" SHELL, WHICH FEATURES A THICKER SHELL WALL, IS A LINE EXTENSION TO THE TRIDENT ACETABULAR SHELLS PREVIOUSLY APPROVED FOR USE WITH THE TRIDENT ALUMINA INSERT.
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