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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 NumberS002
Date Received01/26/2007
Decision Date06/08/2007
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 THE ADDITION OF THE ZIMMER MANUFACTURING B.V. FACILITY LOCATED IN PONCE, PUERTO RICO AS AN ALTERNATIVE SITE FOR MANUFACTURING THE VERSYS HERITAGE FEMORAL STEMS.
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