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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 NumberS006
Date Received04/10/2007
Decision Date11/13/2008
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LINE EXTENSION TO THE BHR SYSTEM (IE., MODULAR VERSION OF THE BHR CUP FOR USES WITH OPTIONAL SCREWS AND APEX/SCREW HOLD COVERS) AND A SITE CHANGE (SMITH & NEPHEW, INC., MEMPHIS, TENNESSEE).
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