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 | S031 |
Date Received | 01/30/2023 |
Decision Date | 07/28/2023 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to device labeling that was updated to include information on the Post-Approval Study (PAS), Long-Term F/u of EU patients PAS, for the R3 Delta Ceramic Hip System |
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