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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 NumberS097
Date Received04/07/2022
Decision Date05/05/2022
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional inspection at the machining and in-process (IPC) process steps for the Pinnacle Cup components of the CERAMAX® Ceramic Total Hip System.
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