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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.
 
DeviceR3TM delta Ceramic Acetabular System
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Rd.
Memphis, TN 38116
PMA NumberP150030
Supplement NumberS043
Date Received08/15/2024
Decision Date09/13/2024
Withdrawal Date08/11/2025
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
updates to product labelling, including Instructions for Use (IFU) and packaging labels, to include additional symbols and MR safety information for the R3 DELTA CERAMIC HIP SYSTEM implants
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