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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 NumberS011
Date Received11/23/2009
Decision Date01/11/2010
Withdrawal Date08/29/2012
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN ALTERNATE TEST METHOD FOR X-RAY DIFFRACTION DETERMINATION (XRD) OF PHASE CONTENT OF THE PLASMA-SPRAYED HYDROXYAPATITE COATINGS AS WELL AS ADDITION OF TWO NEW CONTRACT TESTING FACILITIES (LAMBDA TECHNOLOGIES IN CINCINNATI, OHIO AND EVANS ANALYTICAL GROUP (EAG) IN ROUND ROCK, TEXAS).
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