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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 ACETABULAR HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Rd.
Memphis, TN 38116
PMA NumberP030022
Supplement NumberS006
Date Received05/31/2007
Decision Date10/12/2007
Withdrawal Date08/31/2022
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
Predetermined Change Control Plan AuthorizedNo
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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