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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
Applicant
SMITH&NEPHEW ORTHOPAEDICS
7135 goodlett farms parkway
cordova, TN 38016
PMA NumberP040033
Supplement NumberS031
Date Received01/17/2017
Decision Date02/22/2018
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 Product No
Approval Order Statement 
Approval for a change to the sterilization parameters that will be used for the BHR components from the previously approved dose range of 25-35 kGy to 25-50 kGy.
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