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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 Drive
Mahwah, NJ 07430
PMA NumberP000013
Supplement NumberS009
Date Received04/16/2009
Decision Date05/07/2009
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE LABELING (I.E., SURGICAL PROTOCOL) OF THE TRIDENT HIP SYSTEM. THESE MODIFICATIONS INCLUDE CREATING SEPARATE AND DISTINCT SURGICAL PROTOCOLS, ONE FOR THE TRIDENT PSL SHELL AND ONE FOR THE TRIDENT HEMISPHERICAL SHELL, IN ORDER TO CLARIFY THE DIFFERENCES IN REAMING TECHNIQUES BETWEEN THE TWO SHELLS, AS WELL AS OTHER IMPROVEMENTS TO THE SURGICAL PROTOCOL.
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