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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.
 
DeviceR3 DELTA Ceramic Hip 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 NumberS041
Date Received06/25/2024
Decision Date07/23/2024
Withdrawal Date08/11/2025
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a replacement of the current micrometer with a Nanovea Optical Profilometer PS50 for measuring the overall coating thickness of vacuum plasma spray (VPS) coating of test plates (TP) coated as part of the VPS implant coating process for manufacturing POLARSTEM Stems
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