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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 SYSTEM (BHR)
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantSmith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116
PMA NumberP040033
Supplement NumberS030
Date Received07/29/2016
Decision Date12/21/2016
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a manufacturing site located at Synergy Health Sterilisation UK Ltd., Brunel Close, Drayton Fields Industrial Estate, Daventry, Northamptonshire, UK NN11 8RB for the sterilization of the Birmingham Hip Resurfacing System.
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