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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 Dr.
Warsaw, IN 46582
PMA NumberP070026
Supplement NumberS102
Date Received09/07/2022
Decision Date10/04/2022
Product Code MRA 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Process change by introducing new sealing parameters and the use of six (6) cavities as opposed to the current four (4) cavities that are used to package some components of the CERAMAX Ceramic Total Hip system.
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