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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
Applicant
SMITH&NEPHEW ORTHOPAEDICS
7135 goodlett farms parkway
cordova, TN 38016
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 Product No
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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