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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 (RCHS)
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
Smith & Nephew, Inc.
7135 goodlett farms parkway
cordova, TN 38016
PMA NumberP030022
Supplement NumberS024
Date Received03/21/2013
Decision Date08/06/2013
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A SOFTWARE CHANGE TO ANALYZE THE STIKTITE POROUS COATINGS.
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