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Device | R3TM delta Ceramic Acetabular 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 | S014 |
Date Received | 10/13/2021 |
Decision Date | 09/09/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternative process to mask the device during the Vacuum Plasma Spray (VPS) coating process for the POLARSTEM Stems. |