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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 SYSTEM AND TRIDENT SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantHowmedica Osteonics Corp.
325 Corporate Dr.
Mahwah, NJ 07430
PMA NumberP000013
Supplement NumberS003
Date Received08/13/2003
Decision Date11/13/2003
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE.
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