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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 PACKAGE INSERT
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantZimmer, Inc.
P.O. Box 708
Warsaw, IN 46581
PMA NumberP040048
Supplement NumberS014
Date Received05/02/2011
Decision Date06/02/2011
Withdrawal Date08/29/2012
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING INFORMATION ABOUT MRI SAFETY TO THE PACKAGE INSERT AND PATIENT LABELING.
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