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 |
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 | S048 |
Date Received | 06/06/2022 |
Decision Date | 07/05/2022 |
Withdrawal Date
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08/31/2022 |
Product Code |
MRA |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Manufacturing process change by revising the hydroxyapatite (HA) powder flow limits for the Anthology stems which are approved for use in combination with the Reflection Ceramic Acetabular System. |
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