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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 NumberS002
Date Received06/12/2003
Decision Date09/12/2003
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 FOR REVISIONS TO THE TRIDENT ACETABULAR SYSTEM PACKAGE INSERT AND PATIENT LABELING. THESE CHANGES INCLUDE EDITING TEXT FOR CONCISENESS AND CLARITY, REORGANIZING ELEMENTS TO MORE CLEARLY CONVEY INTENT, AND PRESENTING DATA IN A MANNER THAT IS LESS CONFUSING AND MORE MEANINGFUL TO PATIENTS AND SURGEONS.
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