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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 SYSTEM (BHR)
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantSmith & Nephew, Inc.
1450 Brooks Rd.
Memphis, TN 38116
PMA NumberP040033
Supplement NumberS017
Date Received10/18/2010
Decision Date10/14/2011
Product Code NXT 
Advisory Committee Orthopedic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN ALTERNATIVE SITE FOR THE POROUS COATING PROCESS FOR THE R3 ACETABULAR SHELLS.
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