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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameTRILOGY AB ACETABULAR SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis hip,semi-constrained,metal/ceramic/metal,cemented or uncemented
ApplicantZIMMER, INC.
PMA NumberP040048
Supplement NumberS001
Date Received10/12/2006
Decision Date12/28/2006
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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