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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
Generic Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Applicant
SMITH&NEPHEW ORTHOPAEDICS
7135 goodlett farms parkway
cordova, TN 38016
PMA NumberP040033
Supplement NumberS032
Date Received11/24/2017
Decision Date12/20/2017
Product Code NXT 
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of the in-process visual inspection criteria for the sterile packaging for the subject device.
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