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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 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 NumberS117
Date Received01/24/2025
Decision Date02/21/2025
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  
to introduce an alternate manufacturing consumable (i.e., water-based binder), and associated equipment assets (spray booths, binder rooms) into the metal-porous coating processes
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