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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 SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nametotal hip arthroplasty system
ApplicantSMITH & NEPHEW, INC.
PMA NumberP030022
Supplement NumberS006
Date Received05/31/2007
Decision Date10/12/2007
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the elimination of sterilization cycle 204, a reduction in the required number of process challenge devices (pcd), the increase in the length of pcd tubing, a reduction in the number of pcds that need to be tested when some of the pcds are damaged or lost, and a change in the placement pattern for biological indicators.
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