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 | S032 |
Date Received | 07/27/2015 |
Decision Date | 09/25/2015 |
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 AN INNER LID PACKAGING CHANGE TO BIOLOX FORTE CERAMIC HEADS. |
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