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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
PMA NumberP040048
Supplement NumberS001
Date Received10/12/2006
Decision Date12/28/2006
Withdrawal Date08/29/2012
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ZIMMER, INC., WARSAW, INDIANA FOR DESIGN CONTROL, FINAL PACKAGING AND LABELING OF THE CERAMIC ACETABULAR SHELL COMPONENTS AND APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US LLC, WESTERVILLE, OHIO.
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