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 (RCHS) 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 | P030022 |
Supplement Number | S016 |
Date Received | 07/07/2010 |
Decision Date | 07/30/2010 |
Withdrawal Date
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08/31/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO SMITH & NEPHEW SPECIFICATION M000286 IN TERMS OF THE AVERAGE VOLUME POROSITY OF THE POROUS COATING COMPLYING WITH THE AVERAGE VOLUME POROSITY OF 30% - 70%. |
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