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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 Road
Memphis, TN 38116
PMA NumberP150030
Supplement NumberS036
Date Received09/11/2023
Decision Date04/29/2024
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of an alternative manufacturing facility (Smith And Nephew Operations Sdn. Bhd PMT 797, Persiaran Cassia Selatan 8 Taman Perindustrian Batu Kawan, Bandar Cassia Penang Pulau Pinang, Malaysia 14110) for R3™ Acetabular Shells which are approved for use as part of the P150030 - R3™ Delta Ceramic Acetabular System as well as an additional vendor for sterilization (Synergy Sterilisation(M) Sdn. Bhd., Plot 203, Kuala Ketil Industrial Estate, Kuala Ketil Kedah, Malaysia 09300).
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