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 | S006 |
Date Received | 05/31/2007 |
Decision Date | 10/12/2007 |
Withdrawal Date
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08/31/2022 |
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 THE ELIMINATION OF STERILIZATION CYCLE 204, A REDUCTION IN THE REQUIRED NUMBER OF PROCESS CHALLENGE DEVICES (PCD), THE INCREASE IN THE LENGTH OF PCD TUBING, A REDUCTION IN THE NUMBER OF PCDS THAT NEED TO BE TESTED WHEN SOME OF THE PCDS ARE DAMAGED OR LOST, AND A CHANGE IN THE PLACEMENT PATTERN FOR BIOLOGICAL INDICATORS. |
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