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 | R3 DELTA CERAMIC HIP SYSTEM |
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 | P150030 |
Supplement Number | S017 |
Date Received | 11/08/2021 |
Decision Date | 12/08/2021 |
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 Synergey Health Daniken AG (a.k.a STERIS), Daniken So, Solothurn, 4658 Switzerland as an alternative vendor for gamma sterilization of the R3TM US Delta Ceramic Liner and R3TM US Delta Ceramic Heads. |
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