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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.
 
DeviceTRILOGY AB ACETABULAR SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantZIMMER, INC.
P.O. Box 708
Warsaw, IN 46581-0708
PMA NumberP040048
Supplement NumberS003
Date Received11/30/2007
Decision Date04/11/2008
Withdrawal Date 08/29/2012
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE BY THE SUPPLIER TO IMPLEMENT NEW SOFTWARE TO THE MANUFACTURING LINE TO ALLOW POLISHED INSERTS TO BE REWORKED, FOLLOWING INSPECTION, IN ONE OF THE TWO INNER SPHERE POLISHING STATIONS, WHILE THE OTHER STATION CONTINUES TO BE USED FOR INITIAL PRODUCTION.
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