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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, REFLECTION CERAMIC ACETABULAR HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantSmith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116
PMA NumberP040033
Supplement NumberS012
Date Received07/22/2009
Decision Date10/07/2009
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 ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF NEW MANUFACTURING EQUIPMENT USED TO PRECLEAN DEVICES.
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