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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.
 
DeviceTRIDENT CERAMIC-ON-CERAMIC ACETABULAR SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, NJ 07430
PMA NumberP000013
Supplement NumberS011
Date Received11/10/2011
Decision Date11/02/2012
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR LABELING UPDATES INCORPORATING RESULTS OF THE COMPLETED POST-APPROVAL STUDY.
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