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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 Rd.
Memphis, TN 38116
PMA NumberP040033
Supplement NumberS001
Date Received08/23/2006
Decision Date10/13/2006
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR: 1) ADDITION OF INTERMEDIATE SIZED FEMORAL HEAD COMPONENTS TO THE BHR SYSTEM (40MM, 44MM, 48MM, 52MM AND 56MM); 2) ADDITION OF ACETABULAR CUPS THAT MATE WITH THE INTERMEDIATE SIZED FEMORAL HEAD COMPONENTS (STANDARD, DYSPLASIA AND BRIDGING); AND 3) REVISIONS TO THE BHR LABELING TO REFLECT THE ADDITIONAL INTERMEDIATE SIZED COMPONENTS.
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