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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceR3 DELTA CERAMIC HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116
PMA NumberP150030
Date Received08/20/2015
Decision Date10/17/2016
Product Code MRA 
Docket Number 16M-3430
Notice Date 10/20/2016
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the R3TM delta Ceramic Acetabular System. This device is indicated for use in skeletally mature patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S037 
S038 S039 
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