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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 NumberS021
Date Received02/01/2012
Decision Date06/28/2012
Product Code
MRA[ Registered Establishments with 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 Product No
Approval Order Statement 
APPROVAL FOR ADDITION OF AN ALTERNATE SITE FOR THE MACHINING PROCESSES FOR R3 ACETABULAR SHELLS.
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