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 | BIRMINGHAM HIP RESURFACING SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/metal, resurfacing |
Applicant | Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 |
PMA Number | P040033 |
Supplement Number | S025 |
Date Received | 05/14/2014 |
Decision Date | 08/12/2014 |
Product Code |
NXT |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITION TO THE LABELING FOR THE BIRMINGHAM HIPRESURFACING (BHR) SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM. |
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