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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceCERAMAX Ceramic Total Hip System
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantDEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46582
PMA NumberP070026
Supplement NumberS107
Date Received05/31/2023
Decision Date08/11/2023
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for extending the shelf life from five (5) years to ten (10) years for the Biolox Delta TS Ceramic Femoral Heads, Biolox Delta Ceramic Femoral Heads, and CERAMAX Ceramic Inserts which are components of the CERAMAX® Ceramic Total Hip System.
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