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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.
 
DeviceBIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantSmith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116
PMA NumberP040033
Supplement NumberS024
Date Received11/21/2013
Decision Date12/11/2015
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN UPDATE TO THE DEVICE LABELING TO INCLUDE THE RESULTS OF THE COMPLETED UNITED KINGDOM (UK) POST-APPROVAL STUDY.
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