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. |
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Device | REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS) |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
PMA Number | P030022 |
Supplement Number | S038 |
Date Received | 07/15/2016 |
Decision Date | 12/21/2016 |
Withdrawal Date
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08/31/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Synergy Health Sterilisation UK Ltd., Brunel Close, Drayton Fields Industrial Estate, Daventry, Northamptonshire, UK NN11 8RB for the sterilization of the R3 acetabular shells which are part of the Reflection Ceramic Acetabular Hip System. |
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