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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.
 
DeviceREFLECTION CERAMIC HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116
PMA NumberP030022
Supplement NumberS004
Date Received04/20/2006
Decision Date05/04/2007
Withdrawal Date 08/31/2022
Product Code MRA 
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 OR THE ADDITION OF ANOTHER ETO STERILIZATION PROCESS THAT UTILIZES A 4 HOUR EO EXPOSURE TIME COMPARED TO THE PREVIOUS 2 HOUR EO EXPOSURE TIME, AS WELL AS A CHANGE IN THE ACCEPTABLE NUMBER OF BIOINDICATORS TO REFLECT CURRENT AAMI STANDARDS.
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