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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameREFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nametotal hip arthroplasty system
ApplicantSMITH & NEPHEW, INC.
PMA NumberP030022
Supplement NumberS016
Date Received07/07/2010
Decision Date07/30/2010
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to smith & nephew specification m000286 in terms of the average volume porosity of the porous coating complying with the average volume porosity of 30% - 70%.
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