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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 NumberS039
Date Received12/12/2024
Decision Date01/10/2025
Product Code NXT 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change in packaging to add alternative top foam inserts used in the packaging of specified sizes of BIRMINGHAM HIP RESURFACING (BHR) Acetabular Cups and BHR Femoral Head Implants manufactured at Smith & Nephew Orthopaedics Ltd. (SNOL), Leamington Spa, United Kingdom
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